Career Opportunities

How to Apply

When an opportunity in which you are interested becomes available, please submit your resume or CV, cover letter with job code and salary requirements to the address below. All submissions will be evaluated. Interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for one year.

Open Positions

Associate Director, Biostatistics

Job #: 02-204

Job Title: Associate Director, Biostatistics

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.,
We are seeking an Associate Director to the Biostatistics group
This position will report to the Head of Biometrics and be located in the Waltham, MA office.

Key Responsibilities:
• Serve as a lead statistician and manage statistical efforts for multiple clinical studies and/or a clinical program
• Contribute to clinical protocol development, including authoring of the section on statistical methods and reviewing/editing of other sections by applying statistical principles
• Author statistical analysis plans for studies and/or ISS/ISEs, and author/edit shells for tables, figures and listings
• Review CRF designs to ensure data collection meet the study objectives and the requirements of statistical analyses
• Provide statistical input to data monitoring committee (DMC) charters, project management plan, and other study-level documents
• Work with statistical programmers or CROs to generate tables, figures and listings
• Perform ad hoc and exploratory statistical analyses as needed
• Contribute to clinical study reports, including authoring of statistical sections and interpretation of the study results
• Support regulatory submissions as needed; provide response to regulatory requests independently
• Support the preparation of publications, including manuscripts, posters and oral presentations
• Provide oversight of CROs for outsourced statistical activities and QC key results generated by CROs

Required Qualifications:
• PhD in statistics or a related field with at least 6 years of relevant clinical trial experience or MS in statistics or equivalent with at least 8 years of relevant clinical trial experience
• Knowledge of statistical methods for clinical trials
• In-depth Knowledge of FDA, EMA and ICH regulations and guidelines
• Proficient in statistical programming (SAS is required)
• Experience with trial design software (e.g., EAST or nQuery)
• Good communication skills and ability to work with cross-functional study teams
• Good organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Good analytical and problem-solving skills
• Positive and collaborative attitude

Preferred Qualifications:
• Experience with NDAs/BLAs, MAAs and other regulatory submissions is a plus
• Proficient in running simulations using either SAS or R

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Vice President, Information Technology

Job #: 03-207

Job Title:  Vice President, Information Technology

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. Deciphera (DCPH) is a publicly traded company headquartered in Waltham, Massachusetts.  Our state-of-the-art research facility is located near the University of Kansas School of Pharmacy in Lawrence, Kansas. We offer an outstanding culture focused on:

  • Providing a collaborative and energized work environment
  • A diverse and multi-disciplinary workforce
  • Dedicated and talented people who are passionate about achieving excellence in all they do
  • A commitment to the patients we serve

We are seeking a Vice President, Information Technology to be a key member of the senior leadership team and is responsible for setting the enterprise IT strategy and vision of a rapidly growing, clinical stage biopharmaceutical company. The successful candidate will be well versed with industry trends and cutting-edge technologies. In this role, you will serve as the IT lead for Deciphera responsible for IT governance, technology due diligence and selection, project management and delivery. Key to this role will be balancing the technical aspects of this position with the ability to integrate the company’s corporate strategy with IT priorities.

In this role you will have the opportunity to lead a highly skilled and talented team of IT professionals and build and expand the team across 2 US sites (Waltham, MA and Lawrence, KS).

This position will report to the CFO and be located in the Waltham, Massachusetts office.

Key Responsibilities:

  • Lead and own the development of Deciphera’s IT architectures and roadmap, working closely with the business and solution delivery teams (internal and external) to align and integrate their respective strategies.
  • As the top IT professional in the company, promote teamwork and leadership within IT and across the organization, develop the team’s annual deliverables/objectives, performance goals, and empower them to deliver on Deciphera’s strategic priorities and objectives.
  • Recruit, develop and motivate a highly skilled IT team.
  • Run day-to-day operations of global network, storage, security, enterprise architecture and telecommunications infrastructure (including office automation, phone and video conferencing).
  • Oversight and implementation of IT policies, procedures and plans for security, data center, desktops and infrastructure based on industry-standard best practices, SOX and FDA requirements and validated systems.
  • Evaluate and determine balance between insourced and outsourced IT service models.
  • Manage multiple areas including enterprise data architecture strategy and manage enterprise-wide storage, backup, integration, and accessibility of data, including disaster recovery and business continuity plans.
  • Establish the strong working relationships with senior leaders, operations and technology management, in the capacity of a trusted advisor on IT matters.
  • Communicate the practical implications of system selection and implementation, architectural decisions, issues and plans to senior business, systems delivery, and infrastructure management.
  • Identify and promote opportunities for cross-business sharing/re-use of application components, rationalization of application portfolios and integrated architectures across the company.
  • Establish Project Management capabilities to apply rigor to portfolio analysis (including sequencing of projects), budgeting & planning, tracking and resolving issues, risks and dependencies across projects and programs, and directing executive communications/status reporting, resource management and staffing needs.

Required Qualifications:

  • Bachelor’s degree in Computer Science or related field. MBA a plus.
  • 15+ years as an information technology/information system leader with previous experience in biotech or pharmaceutical environment.
  • Must have a proven track record of building relationships founded on credibility and trust and bring strong leadership to the team and create an environment that promotes professional development and growth.
  • Experience developing, leading and successfully executing an IT vision and direction including demonstrated experience developing long- and short-term strategic IT plans, developing the associated financial analyses and translating budgeted plans into tactical, actionable operational initiatives.
  • Demonstrated leadership and experience attracting and developing strong IT talent.
  • Ability to manage, coach and mentor high functioning IT teams.
  • Prior commercial experience in a pharmaceutical, biotechnology or related environment, including scaling of the organization. Global experience a plus.
  • Demonstrated ability to effectively collaborate and communicate with a variety of stakeholders including all employees, executive and senior management, partners and vendors.
  • An active listener with the ability to proactively and confidently engage with key stakeholders to gain an understanding of the business’ evolving IT needs, develop and recommend innovative and cost-effective solutions and explain technology-related issues to non-technical audiences.
  • Hands-on experience as a project manager with strong planning skills, the ability to set and manage expectations and deliver on projects within the committed timeframe and budget.
  • Ability to analyze problems and resolve conflicts.

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Recruiting Coordinator (Contractor)

Job #: 03-206

Job Title: Recruiting Coordinator (Contractor)

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We offer an outstanding culture focused on:
• Providing a collaborative and energized work environment
• A diverse and multi-disciplinary workforce
• Dedicated and talented people who are passionate about achieving excellence in all they do
• A commitment to the patients we serve

We are seeking a Recruiting Coordinator (Contractor) to be an integral part of the Human Resources team and collaborate with people from all departments and functions. In this highly visible role you will support candidates and hiring managers through all stages of recruiting and on-boarding.

This position will report to the Director, Talent Acquisition and Senior HR Business Partner and be located in the Waltham, MA office.

Key Responsibilities:
· Coordinate and schedule candidate interviews
· Manage job postings and applicant tracking system
· Candidate offer letters
· Greet and provide general support to guests and candidates
· Manage the new hire onboarding process
· Support Talent Acquisition team
· Partner with the HR team on employee communications, employer branding, employee referral and other promotional programs

Required Qualifications:
· Bachelor’s degree with 1 + years of relevant work experience
· Energetic, can do attitude
· Great communication and writing skills
· Excellent customer service skills and attention to detail
· Strong MS office skills including – Outlook, PowerPoint and Excel
· Experience with Applicant Tracking Systems a plus

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director, Clinical Pharmacology

Job #: 02-241

Job Title: Associate Director, Clinical Pharmacology

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment. We offer an outstanding culture focused on:
• Providing a collaborative and energized work environment
• A diverse and multi-disciplinary workforce
• Dedicated and talented people who are passionate about achieving excellence in all they do
• A commitment to the patients we serve

We are seeking an Associate Director, Clinical Pharmacology to contribute to scientific and strategic planning, oversight of projects, management of external vendors, analysis of clinical data, and documentation for NDA-directed development programs for Deciphera’s drug candidates in the area of clinical pharmacology.

This position will report to the Director, Clinical Pharmacology and be located in the Waltham, Massachusetts office.

Key Responsibilities:
• Act as the lead clinical pharmacologist for one or more oncology programs
• Work in close partnership with Medical, Clinical Operations, Biostatistics and Translational Research to advance these programs from Phase I to late-stage development
• Responsible for designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials
• Draft clinical pharmacology components of protocols, investigator’s brochure and other regulatory documents
• Analyze pharmacokinetic (PK) data and integrate this knowledge into clinical trials and the overall clinical program
• Oversee bioanalytical analysis, partner with external vendors
• Provide ad-hoc support to other programs as needed

Required Qualifications:
• A M.S., Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences or related disciplines
• M.S. with 10 years of PK experience or Ph.D./PharmD with 5 years of PK experience. At least 3-year experience in Clinical Pharmacology
• Strong understanding of clinical pharmacokinetic concepts
• Strong technical proficiency in PK analysis (NCA and PopPK)
• Familiar with PK assay development and sample analysis process
• Working knowledge of DMPK and Toxicology
• Effective verbal and written communication skills are essential for the role

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director/Director, Corporate Counsel

Job #:03-205

Job Title: Associate Director/Director, Corporate Counsel

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Corporate Counsel to provide general advice across all functions, with a focus on contracts. We are seeking a dynamic and collaborative life science attorney who wants to contribute to the growth of a thriving, fast-paced biotech.

This is an outstanding opportunity to be the second lawyer to join the legal function at a well-funded, clinical stage biotech company with the potential to commercialize a lead oncology asset currently in Phase 3. In this role you will be a generalist with a focus on negotiating contracts and providing legal advice on contract escalation issues. You will have the opportunity to work cross functionally across the company and contribute to important strategic initiatives as well as operational matters.

This position reports to the General Counsel and be located in the Waltham, MA office.

Key Responsibilities:
• Provide primary legal support on contracts and help improve and evolve the contracting process.
• Lead the negotiating and drafting of contracts customary to a fast-growing clinical-stage biotech company that is preparing to launch its first product, including:
o Clinical: support the clinical operations team and outside counsel by resolving legal escalation issues on site CTAs, CDAs, ICFs and CRO contracts, and related documents
o Research: work on complex research and licensing transactions with contract research organizations and academic institutions
o Supply Chain: negotiate clinical supply and contract manufacturing agreements
o Commercial: negotiate distribution and related agreements
o Vendor: negotiate consulting and professional services agreements, lab vendor agreements, and other important vendor contracts in coordination with the procurement manager
• Manage outside counsel in the United States and Europe

In addition to contracts, based on your skills and the needs of the business, you will provide legal expertise on the following matters/areas:
• SEC/Governance
• Healthcare law and compliance
• HR support
• Real Estate and Insurance
• Patient Advocacy and ad/promo/marketing reviews
• Strategic transactions

Required Qualifications:
• Excellent academic qualifications, JD required; candidates should have a minimum of 5–10 years’ experience including biotech/pharma experience. License and collaboration experience preferred.
• License to practice Law in Massachusetts
• Excellent interpersonal and client relation skills
• Ability to work in a fast-paced environment leveraging internal and external resources to meet simultaneous deadlines/demands
• Willingness to pitch-in and help on legal projects across the organization
• Experience with implementing a contract management system; create and manage contract templates; train business partners on contracts policy
• Excellent research, writing, counselling and communication skills and a positive client service orientation
• Ability to work independently, as a team member, and across the organization
• Accountability, sound judgment, and the ability to take ownership of an issue and provide concise and timely advice

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Senior Director, Drug Substance Manufacturing Science & Technology (MS&T)

Job #: 02-239

Job Title: Senior Director, Drug Substance Manufacturing Science & Technology (MS&T)

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Director, Drug Substance MS&T, who will have overall responsibility for leading and managing late-stage development and commercial manufacturing activities for drug substance, DS intermediates and starting materials. The scope of the role encompasses process development, scale-up, and characterization/design space mapping, process performance qualification (PPQ), routine commercial manufacturing, technical transfer and process/operational improvement initiatives. Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and oversight, and the development of strong and enduring business partnerships. The successful candidate will also assume a key leadership role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs, and will support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements.

The successful candidate will have significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills, ensuring that external business partners understand and respect program goals, objectives, priorities, and timelines.

This position will report to the Chief Technical Officer and be located in the Waltham, MA office.

Key Responsibilities:

• Lead and manage cross-functional teams engaged in external cGMP manufacturing of drug substance, DS intermediates, and starting materials.
• Lead and manage process transfers and associated site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
• Monitor, track and trend process performance. Develop and implement data analytics to support investigations and provide historical baseline for future operational and process-related improvements.
• Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.
• Work closely with internal Quality Assurance, Regulatory CMC, Supply Chain and Commercial functions and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and
business goals/milestones.
• Lead the selection of drug substance CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance.
• Develop and maintain strong relationships with CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain.
• Review/approve technical reports, controlled GMP documents and CMC content for Module 3 CTDs.
• Develop and manage scope, milestones, interdependencies, budgets and timelines associated with drug substance program deliverables.
• Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk.
• Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of drug substance program deliverables with overall program strategy.
• Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.

Required Qualifications:

• A B.S./M.S. degree in chemistry, chemical engineering or related life sciences discipline with at least 15 years of experience in small-molecule pharmaceutical product development and commercialization.
• Track record of success in leading and managing small-molecule drug substance MS&T programs in a 100% outsourced environment.
• Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
• Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
• Strong decision-making skills and ability to influence internal and external stakeholders.
• Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval
and commercialization.
• Ability to articulate complex issues and ideas with clarity to enable understanding and decision making.
• Ability to work successfully in a team/matrix environment and independently, as required.
• Ability to influence cross-functionally to enable improvements and enhance performance across CMC development, MS&T and supply chain functions.
• Pragmatic, solution-oriented thinker who possesses a “can do” and ”whatever it takes” attitude, coupled with excellent organizational and communication skills.
• Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
• Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools). 

Preferred Qualifications:

• Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
• A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired.

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Senior Director, Drug Product Manufacturing Science & Technology (MS&T)

Job #: 02-238

Job Title: Senior Director, Drug Product Manufacturing Science & Technology (MS&T)

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Director, Drug Product MS&T, who will have overall responsibility for leading and managing late-stage development and commercial manufacturing activities for drug product and packaging. The scope of the role encompasses process development, scale-up, and characterization/design space mapping, process performance qualification (PPQ), routine commercial manufacturing, technical transfer and process/operational improvement initiatives. Operating within a virtual (100% outsourced) business model, the incumbent will have accountability for CDMO selection and oversight, and the development of strong and enduring business partnerships. The successful candidate will also assume a key leadership role in the development, review and approval of Module 3 sections of CTD regulatory submissions, written responses to regulatory authorities, and TPP/QTPPs, and will support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements.

The successful candidate will have significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills, ensuring that external business partners understand and respect program goals, objectives, priorities, and timelines.

This position will report to the Chief Technical Officer and be located in the Waltham, MA office.

Key Responsibilities:

• Lead and manage cross-functional teams engaged in external cGMP manufacturing of bulk drug product and finished goods.
• Lead and manage process transfers and associated site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
• Monitor, track and trend process performance. Develop and implement data analytics to support investigations and provide historical baseline for future operational and process-related improvements.
• Support investigations, root cause identification and CAPA implementation associated with manufacturing deviations and associated quality events.
• Work closely with internal Quality Assurance, Regulatory CMC, Supply Chain and Commercial functions and external manufacturing operations to ensure operational excellence with respect to timelines, budgets, and attainment of technical, regulatory
and business goals/milestones.
• Lead the selection of drug product CDMOs based upon core capabilities, capacity and track record of regulatory compliance; establish KPIs to monitor site technical, quality and business performance.
• Develop and maintain strong relationships with CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain.
• Review/approve technical reports, controlled GMP documents and CMC content for Module 3 CTDs.
• Develop and manage scope, milestones, interdependencies, budgets and timelines associated with drug product program deliverables.
• Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk.
• Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of drug product program deliverables with overall program strategy.
• Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities.

Required Qualifications:
• A B.S./M.S. degree in pharmaceutics, chemistry, chemical engineering or related life sciences discipline with at least 15 years of experience in small-molecule pharmaceutical product development and commercialization.
• Track record of success in leading and managing small-molecule drug product MS&T programs in a 100% outsourced environment.
• Strong vendor/supplier management skills and excellent communication and cross-functional collaboration skills.
• Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
• Strong decision-making skills and ability to influence internal and external stakeholders.
• Thorough knowledge of the drug development process and ICH requirements for NDA and MAA registration. Extensive experience in working with regulatory authorities. Track record of authoring and defending Module 3 CTD content through regulatory approval
and commercialization.
• Ability to articulate complex issues and ideas with clarity to enable understanding and decision making.
• Ability to work successfully in a team/matrix environment and independently, as required.
• Ability to influence cross-functionally to enable improvements and enhance performance across CMC development, MS&T and supply chain functions.
• Pragmatic, solution-oriented thinker who possesses a “can do” and ”whatever it takes” attitude, coupled with excellent organizational and communication skills.
• Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
• Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
• Ability to travel (20%) to CDMO domestic and international sites.
• Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project) and JMP (or similar statistical tools). 

Preferred Qualifications:
• Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
• A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired.

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Director, Regulatory CMC

Job #: 02-237

Job Title: Director, Regulatory CMC

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director, Regulatory CMC to provide Regulatory CMC leadership across multiple development programs.

This position will report to the Vice President Regulatory Affairs & Quality and be located in the Waltham, MA office.

Key Responsibilities:
• Develop and implement CMC regulatory strategies for investigational products
• Work closely with Regulatory, Manufacturing, and Quality to support investigational product activities and maintenance of submissions
• Act as point of contact with FDA for CMC regulatory matters for investigational products.
• Lead cross-functional resources to compose high quality, global CMC investigational and marketing dossiers
• Ensure regulatory documents are comprehensive, complete and accurate
• Maintains dialogue with regulatory agencies/personnel in support of clinical trial applications, including development of responses to Regulatory Agency CMC questions or requests for information
• Monitor the development of new requirements, guidelines and trends through information gathering and participation in industry groups
• Contribute to the development and implementation of RA best practices, quality systems, operating procedures and policies

Required Qualifications:
• Master of Science (or Bachelor of Science with sufficient professional experience) in a scientific discipline (ex. chemistry, biochemistry, etc)
• Minimum of 8 years CMC experience, including at least 4 years in Regulatory CMC
• Must have experience with small molecules
• Must have experience with early and late stage development programs and must have recent NDA experience
• Experience/background and training in all aspects of Regulatory Affairs including:
o Expert understanding of FDA guidelines/regulations/requirements
o Working knowledge of EMA & Canadian guidelines/regulations/requirements
o Working knowledge of Ex-US and Ex- European guidelines/regulations/requirements
• Experience in eCTD submissions
• Ability to interact effectively in a matrixed project team environment
• Strong verbal and written communication skills
• Strategic thinker with a forward-looking perspective
• High level of initiative and commitment
• Must be authorized to work in the US
• Involves some travel (<15%)

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director, Medical Writing

Job #: – 02-236

Job Title: Associate Director, Medical Writing

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking an Associate Director, Medical Writing to be responsible for providing Medical Writing leadership for late stage clinical and regulatory affairs activities.

This position will report to the Vice President Regulatory Affairs & Quality Assurance and be located in the Waltham, MA office.

Key Responsibilities:
• Coordinate document development strategies with various functional areas in Clinical Development and Regulatory Affairs to produce high quality work that is compliant with GCP and ICH guidelines
• Act as Lead Medical Writer
• Represent Medical Writing on cross-functional clinical and regulatory teams and actively participate in NDA submission planning and documentation
• Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames

Required Qualifications:
• Experience in development of clinical documents related to late phase studies.
• NDA experience with active contribution in planning and preparation of summary documents is required
• Bachelor’s Degree; Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
• 10+ years of industry experience as a Medical Writer with experience working in a small biopharmaceutical company

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Senior Clinical Project Manager

Job #: 02-233

Job Title: Senior Clinical Project Manager

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.,
We are seeking a Senior Clinical Project Manager (SCPM) to manage large and complex clinical trials from initiation to completion through leading internal and external cross-functional disciplines, and may include international investigational sites.

This position will report to a Director, Clinical Operations and be located in the Waltham, MA office.

Key Responsibilities:
• May simultaneously lead / manage more than one clinical trial
• Provide input as subject matter expert for study during regulatory inspections
• Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight
• Train investigational sites and vendors on study protocol
• Support department initiatives and process improvements
• Mentor other clinical operations staff
• Responsible for the operational implementation of pre-market and post-market clinical trials
• Develop and manage the project plan and timeline, which may include budget planning
• Present ongoing study updates to senior leadership
• Manage escalation of study-related issues and communicate as appropriate with management
• Select and manage clinical trial vendors such as CROs and external laboratories, and ensure their performance is consistent with Deciphera standards
• Collaborate with clinical supply team on selection and management of an IxR vendor
• Provide input and coordinate the on-schedule delivery of clinical trial supplies in collaboration with clinical supply team and relevant vendors
• May perform periodic visits to investigational sites and CROs to assess study progress and compliance
• Assist and participate in planning and conduct of investigator meetings
• Oversee the authoring and management of study-related plans and manuals (e.g. project management plan, site monitoring plan, safety management plan, patient recruitment plan, risk management plan, data management plan, study reference manual, regulatory binder, central lab manual, pharmacy manual, statistical analysis plan, etc.)
• Facilitate the development of study templates such as investigational study budget, informed consent form, and source documents
• Participate in the development of study protocols by coordinating with the medical writer
• Participate in authoring the clinical study report as well as the clinical portion of regulatory submissions
• Participate in review of scientific abstracts and manuscripts
• Select and manage investigational sites
• Serve as a resource for vendors, site coordinators, investigators, and other staff members regarding investigational products and protocols
• Ensure site monitoring is sufficient such that documentation from investigators and investigational sites meets FDA/GCP/ICH requirements and fulfills the study objective
• May review clinical monitoring reports and related correspondences
• Provide input on case report form design and EDC system requirements
• Monitor the status of clinical data collection and query trends

Required Qualifications:

 

  • Bachelor’s degree in health profession and/or science
  • A minimum of 5 years of relevant clinical operations experience in the pharmaceutical industry
  • Global study management experience
  • Excellent verbal and written communications skills
  • Self-motivated, with strong organizational skills and attention to detail
  • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint)
  • Ability to travel approximately 20%

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Senior Director, Quality Assurance and Compliance

Job #: 02-232

Job Title: Senior Director of Quality Assurance and Compliance

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Director of Quality Assurance whose responsibilities will encompass all aspects of Quality Assurance, from strategic planning to hands-on implementation. This person is responsible for the strategy, implementation & leadership of the Quality function at Deciphera and is accountable for the execution and administration of the GxP Quality System pertaining to GLP, GMP, GCP and relevant ICH, US, EU and international regulations.
This position will report to the VP Regulatory Affairs & Quality Assurance, and be located in the Waltham, Massachusetts office.

Key Responsibilities:

• Ensure overall Quality & Compliance oversight for manufacturing, nonclinical, clinical and commercial supply chain activities
• Establish & maintain phase-appropriate Quality Management Systems
• Ensure appropriate Quality oversight of external vendors (CMOs, CROs, etc.)
• Ensure oversight of Deciphera’s internal Quality Systems training program.
• Plan & oversee day-to-day activities of the Quality function including management of existing experienced quality staff and consultants/auditors, to ensure project & business needs are met
• Establish Change Control Review Board and others as needed
• Evaluation of external vendors to include onsite auditing
• Manage the APQR and GMP Management Review Committee
• Work with the regulatory, manufacturing, clinical and nonclinical functions to further build out the Quality function to support the expanding Deciphera organization
• Develop and oversee appropriate Quality metrics and report on the state of Deciphera’s compliance to senior management
• Lead preparations for and management of any Regulatory Agency inspections, including PAI inspection readiness activities
• Provide leadership & mentorship to the Quality team
• Ability to travel approximately 10-15% of the time

Required Qualifications:

• BS in Chemistry, Pharmacy, Biology or a related pharmaceutical science.
• 15+ years of progressive managerial experience within the Quality function of a pharmaceutical company. Experience leading a Quality function is required.
• Experience working in small biopharmaceutical company and/or experience working within a virtual manufacturing company utilizing multiple contract manufacturing organizations is preferred
• Recent experience (within the last 5 years) supporting initial marketing authorizations is required
• Extensive knowledge and experience in GxP and QA principles, practices & industry standards
• Experience with oral small molecule development programs, from early-stage through to commercial
• A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
• Experience with using risk-based principles & decision making to ensure compliance at all stages of development
• Proven track-record of leadership & building relationships with both internal & external customers
• Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Associate Director, Quality Control

Job #: 02-231

Job Title:  Associate Director, Quality Control

Location:  Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking an Associate Director, Quality Control, who will have responsibility for leading and managing the pharmaceutical GMP quality control activities associated with development and commercialization of the company’s small-molecule assets. Operating within a virtual (100% outsourced) business model, the incumbent will be responsible for site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components, review/approval of protocols, methods, reports, batch records and related GMP source documents, oversight of stability operations and reference standard management, and transfer/site implementation of analytical methods to support future supply chain expansion.

The successful candidate will also work collaboratively with Quality Assurance to assess laboratory conformance with cGMPs, and with CMC Regulatory Affairs to ensure the translational accuracy and integrity of data incorporated into Module 3 sections of CTD regulatory submissions and written responses to regulatory authorities.

This position will report to the Senior Director, Analytical Development and MS&T and be located in the Waltham, MA office.

Key Responsibilities:

  • Manage/oversee qualification and site implementation of IPC and QC methods for drug substance, drug product, intermediates, starting materials, excipients, and packaging materials and components.
  • Manage/oversee analytical method transfers and site implementation to support supply chain expansion activities and post-approval continuous improvement initiatives.
  • Manage/oversee stability operations and reference standard program.
  • Participate in the selection of analytical CROs/CDMOs based upon core capabilities and regulatory compliance.
  • Review/approve controlled GMP documents, e.g., analytical methods and associated validation protocols, specifications, change controls, LIRs, etc.
  • Review/approve development reports for data integrity and regulatory compliance; review/approve CMC content incorporated into Module 3 sections of CTD regulatory submissions for translational accuracy.
  • Support cGMP audits of CDMO laboratories.
  • Author and/or review standard operating procedures (SOPs) relating to analytical development and quality control.
  • Maintain effective communication with CDMOs and deliver QC objectives in accordance with project timelines and budgets.

Required Qualifications:

  • S./M.S. degree in analytical chemistry or related life sciences discipline with at least 10 years of quality control experience in pharmaceutical product development.
  • In-depth understanding of CMC regulatory requirements for product registration and cGMP compliance requirements for pharmaceutical quality control laboratories.
  • Strong vendor/supplier management and cross-functional collaboration skills.
  • Ability to work successfully in a team/matrix environment and independently, as required.
  • Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
  • Ability to convey both written and verbal information effectively and efficiently.
  • Ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
  • Ability to travel (15%) to CRO/CDMO domestic and international sites.

 Preferred Qualifications:

  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is desirable.
  • Significant work experience in a virtual (100% outsourced) biopharmaceutical development business model is strongly preferred.

 

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

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Director/Senior Director, CMC Program Management

Job #:02-230 – Director-Senior Director, CMC Program Management 9.14.2018

Job Title:Director/Senior Director, CMC Program Management

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immunotargeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director/Senior Director, CMC Program Management, who will have responsibility for leading and managing cross-functional CMC teams engaged in the development and commercialization of the company’s small-molecule assets. Operating within a virtual (100% outsourced) business model, the incumbent will be accountable for team strategy and deliverables, ensuring operational excellence with respect to timelines, budgets, and attainment of technical, regulatory and business goals/milestones. The successful candidate will also play a central role in the development of strong and enduring relationships with CDMO business partners, and support strategic partnerships relating to potential in-licensing and/or out-licensing opportunities and external collaboration agreements.

The successful candidate will have significant experience in CMC development and commercialization of small molecules and an in-depth understanding of critical-path activities and interdisciplinary connections associated with product registration and commercial launch. S/he will possess strong leadership, management and communication skills, ensuring that team members understand and respect program goals, objectives, priorities, and timelines.

This position will report to the Chief Technical Officer and be located in the Waltham, MA office.

Key Responsibilities:

  • Develop and maintain fully integrated CMC project plans, incorporating activities, internal/external resource requirements and key interdependencies, that deliver tangible results against program and corporate goals.
  • Establish and implement operational mechanisms to facilitate effective and timely cross-functional communication and decision making, and successful execution of program plans.
  • Lead data-driven decision-making processes to enable timely and objective recommendations for continuation, acceleration, reprioritization, redesign or termination of program workstreams.
  • Identify, define, prioritize and communicate risks to successful program execution; develop and monitor risk mitigation and contingency plans.
  • Develop and manage program budgets, AOP/LRP forecasts and quarterly accruals.
  • Communicate progress at all levels and escalate critical issues; provide regular status reports to executive leadership and functional area management.
  • Support development and implementation of PM systems and best practices to ensure consistency and operational effectiveness within and across programs.
  • Develop and maintain strong relationships with CRO/CDMO business partners and participate in quarterly Joint Steering Committees across the supply chain.
  • Continuously monitor external business and regulatory environments; identify risks and establish mitigation plans and/or best practices to proactively address CMC and supply chain risk.
  • Serve as an integral member of the Technical Operations Leadership Team, ensuring cross-functional alignment of program strategy.
  • Represent the Technical Operations organization in meetings with FDA, EMA and related regulatory authorities, as required.

Required Qualifications

  • B.S./M.S. degree in an engineering or life sciences discipline with at least 10 years of experience in small-molecule CMC development and commercialization
  • Track record of success in leading and managing cross-functional CMC teams, ideally within a 100% outsourced environment.
  • Competency in developing, implementing and delivering CMC project plans (milestones, timelines, resources, etc.) to successful endpoints.
  • Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in a crossfunctional team environment, fostering open communication, mutual understanding and cooperation.
  • Pragmatic, solution-oriented thinker who possesses a “can do” and “whatever it takes” attitude, coupled with excellent organizational and communication skills.
  • Strong interpersonal skills with the ability to motivate and influence others, negotiate during situational conflict, and establish the best forward path in the face of competing points of view.
  • Track record of collaboration, stakeholder relationship management, and influencing key decision makers.
  • In-depth knowledge of the drug development process and ICH requirements for NDA and MAA registration. Prior experience working with regulatory authorities.
  • Understanding of industry trends, practices, techniques and standards, and associated impact on program strategy and execution.
  • Ability to articulate complex issues and ideas with clarity to enable understanding and timely decision making.
  • Ability to travel (10-15%) to CRO/CDMO domestic and international sites.
  • Fluency with standard computer software packages (MS Word, Excel, PowerPoint, and Project).

Preferred Qualifications:

  • Experience in developing and commercializing drugs for oncology and/or orphan diseases is strongly preferred.
  • A Ph.D. degree in an engineering or life sciences discipline or M.B.A. in operations management is highly desired.
  • Track record of authoring and defending Module 3 CTD content through regulatory approval and commercialization is advantageous.Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

02-230

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Senior Manager/Associate Director of Program Management

Job #: 03-201.pdf

Job Title: Senior Manager/Associate Director of Program Management

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Senior Manager/Associate Director of Program Management

This position may be filled at the Senior Manager or Associate Director level, based on candidate’s skills/experience, and will report to the Director of Program Management at Deciphera’s corporate headquarters in Waltham, MA.

Key Responsibilities:

    • Collects and compiles project information and plans from each functional group (Clinical, CMC, Regulatory, Pharmacology, etc.) as a team member, through internal reporting systems, and direct communications.
    • The successful candidate will apply their project management skills to one or more of three ongoing clinical-stage programs, developing an integrated project plan for each program in collaboration with the functional groups.
    • Provides overall project timeline and interdependencies using critical path planning and other project management methods and tools.
    • Provides risk analysis on project plans, and highlights key risk factors and scenarios for mitigation planning.
    • Sets agendas, conducts meetings, and writes minutes for various meetings, teams, and sub-teams.
    • Trains/coaches/mentors team members and other functional areas in PM systems, procedures, and tools.
    • Analyzes the impact of portfolio and resourcing decisions on projects/programs; develops contingency plans, with assistance from team.
    • Assists management in the selection of action plans that best meet business objectives.
    • Builds and manages overall project budgets through close communication with functional areas and Finance.
    • Manages projects for external development partnerships/alliances, as needed, and works with partner PM, as appropriate.

Basic Qualifications:

    • B.S., M.S., MBA, or Ph.D. in a science or business-related field.
    • Minimum of 5-years project management experience required, including management of large complex programs and cross-functional teams.
    • Proven experience leading teams as a project manager.
    • Knowledge of drug development and generally accepted PM practices, including budgeting, finance, portfolio review, and team management skills.
    • Strong communication, problem-solving, and interpersonal skills. Ability to influence without authority.
    • Proficiency with MS Project or similar project management tools.
    • Team and drug development or project management related experience.
    • Demonstrated leadership skills with broad business orientation.

Preferred Qualifications:

    • M.S. or Ph.D. in a science or business-related field.
    • 5-7 years of experience in areas of drug development/clinical development/safety.
    • Advanced knowledge of project management practices, including budget, finance, portfolio review, and team management skills.
    • PMP certification is a plus.
    • Experience leading drug development projects.
    • Experience managing early stage development projects or projects moving to commercial.
    • Experience with managing oncology projects a plus. General knowledge across multiple therapeutic areas.

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for health care and/or dependent.

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Director of Pharmacovigilance

Job #: 02-219

Job Title: Director of Pharmacovigilance

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.

We are seeking a Director of Pharmacovigilance to work with Clinical Development to assist in advancing Clinical Programs.

This position will report directly to VP Clinical Development and Translational Medicine.

Key Responsibilities:

    • Responsible for global pharmacovigilance for marketed and/or investigational products, including review and analysis of safety data from post-­‐‑marketing    sources and from clinical trials, the identification and investigation of safety signals, management of benefit-­‐‑risk profile for assigned compounds and products.
    • Accountable for all PV-­‐‑activities associated with filing and approval of US and EU marketing applications.
    • Responsible for keeping upper management informed of safety issues and may work with clinical programs as medical advisor.  May represent Deciphera Drug Safety and    Risk Management at internal and external meetings.
    • The successful candidate will demonstrate the flexibility and capability to function at a high level across various Oncology indications and will be comfortable working    in an entrepreneurial environment to advance the safety and biological understanding of compounds through life cycle.
    • The individual who assumes this position will interact with multiple levels of management within Deciphera, external stakeholders in the medical community as well with global regulatory authorities.  Perform medical review of single cases for assigned products.
    • Manage safety surveillance for assigned compounds/products. Manage collection, in cooperation with a PV vendor, of current data for safety signaling and identify and investigate safety signals.  Conduct analysis of safety data.  Ensure adequacy of recording, summarizing, and handling of adverse events for investigational and/or marketed Deciphera products including decisions on seriousness, expectedness, and causality.  Contributing to the development and implementation of risk minimization action plans.
    • Provide safety strategic leadership for clinical development programs/program teams. Integrate the safety scientific component to build a strategic framework for clinical development plans.
    • Develop and maintain relationships with program counterparts in Clinical Development, Pre-Clinical Safety, Research, Regulatory, Clinical Operations, Clinical Pharmacology, Translational Medicine.
    • Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities.

Basic Qualifications:

    • MD, or MD PhD, or MD MPH required; sub specialty training highly desirable
    • Minimum of 5-years of experience in clinical development or drug safety required, including management of large complex programs and cross-functional teams
    • Excellent communication skills (oral and written) and excellent organizational skills.
    • Demonstrated leadership skills with broad business orientation

Demonstrated sense of urgency and accountability for both individual and team-owned work products.

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E-mail

All e-mails should include the specific job code in the subject line, resumes should be attached as PDF’s and sent to  careers@deciphera.com.
No phone calls please.