How to Apply

When an opportunity in which you are interested becomes available, please submit your resume and 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.


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.


Open Positions

Associate Director/Director, Clinical Scientist

Job #:02-250

Job Title: Associate Director/Director, Clinical Scientist

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

Position Summary:
This position may be filled at Associate Director or Director level based on candidate’s skills/experience and will report to the Sr Director, Clinical Research at Deciphera’s corporate headquarters in Waltham, MA.

Key Responsibilities:
• Works closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
• Assists Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts
• Drives the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
• Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies
• Monitors real time study data to ensure the integrity of the study and the study data and interacts with investigators and internal and external experts to resolve any study issues as they arise
• Involved in high level data cleaning activities requiring clinical judgment Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
• Acts as clinical/scientific expert on the products and studies in the therapy area
• Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
• Works with investigative sites to answer protocol related questions, resolve study conduct and design issues
• May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings

Required Qualifications:
• MS in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN or other equivalent clinical qualifications
• 8 years’ experience in product & clinical development (Clinical Scientist role) in Biotech or Pharmaceutical company
• Understanding of GCP, ICH and regional/local regulations
• Experience in both early and late phase development
• Medical knowledge and experience in clinical development/ operations (Oncology preferred)
• Experience reviewing clinical data outputs
• Ability to perform literature searches and to utilize library services
• Ability to conduct basic data analyses using Excel and other tools
• Basic understanding of biostatistics to allow effective interaction with biostatistics expert
• Requires approximately 15-30% travel

Preferred Qualifications:
• Teaching capability
• Excellent communication skills, both verbal and in writing
• Strong presentation skills
• Team player
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional matrix team
• Diplomacy and positive influencing abilities
• Experience building data presentation plans

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.

Close
Associate Director, SAS Programmer

Job #::02-249

Job Title: Associate Director, SAS Programming

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

Position Summary:
We are seeking an Associate Director, SAS Programming to join our biometrics group.
This position will report to the Senior Director, Head of Biometrics and be located in the Waltham, MA office.

Key Responsibilities:
• Serves as a lead programmer for a compound or key NDA related activities
• Efficiently manage CROs to meet timelines and expectation of quality
• Works collaboratively with other functions to ensure clarity, accuracy and consistency of case report forms (CRFs), develop and comply with project/study programming standards and specifications according to regulatory guidelines
• Programs for SDTM data mapping and creation of ADaM datasets and the corresponding specifications according to CDISC standards
• Programs TLFs for implementation of the statistical analysis plans and for AdHoc analysis in clinical trial of all phases
• Performs programming QC on TLFs
• Tracks clinical trial milestones and works with vendors for statistical reporting deliverables.
• Maintains records for all assigned projects and archiving of trial/project analysis and associated documentation
• Understands and performs in accordance with regulatory standards, and drug development principles
• Responsible for the creation and accuracy of Regulatory submission data and clinical summary report package
• Plans, develops, tests, and documents SAS macros for programming efficiency

Required Qualifications
• 8+ years in statistical programming within the Pharmaceutical industry
• Strong understanding of clinical trial processes and statistical programming requirements for regulatory submissions
• Excellent SAS Software Programming skills, including Base SAS, SAS/STAT, SAS/GRAPH and macro development
• Ability to define and implement CDISC compliant SDTM and ADaM data and specifications
• Oncology experience is a plus

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

Close
Principal/Associate Director, Statistician

Job #::02-247

Job Title: Principal/Associate Director, Statistician

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

We are seeking a Principal/Associate Director, Statistician to join the Biostatistics Group.
This position will report to the Senior Director, 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:
• Principal Statistician: PhD in statistics or a related field with at least 4 years of relevant clinical trial experience or MS in statistics or equivalent with at least 6 years of relevant clinical trial experience
• Associate Director, Statistician: 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.

Close
Senior Clinical Data Manager

Job #::02-246

Job Title: Senior Clinical Data Manager

Location: Waltham, MA

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

We are seeking a seasoned Clinical Data Manager who can lead and contribute to data management activities in support of Deciphera studies across all stages of clinical drug development. This position will report to the Associate Director of Data Management and will be located in the Waltham, MA office.

Key Responsibilities:
• Contribute to data management activities as a lead study data manager in support of Deciphera clinical studies
• Participate in the development of all Data Management documentation including the Data Management Plan, CRF Completion Guidelines, Data Validation Specification, E-Data Reconciliation Plans, Data Review Plan, etc.
• Perform clinical data processing/management including query generation, electronic data reconciliation etc.
• Plans and oversees execution of User Acceptance Testing
• Assist in preparing clean databases, including reviewing responses to queries for appropriateness, resolve any discrepancies and modifying the database accordingly
• Ensures study compliance with SOPs and regulations
• Identify and troubleshoot operational problems, issues, obstacles and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Ability to communicate well and represent data management effectively and diplomatically in a project team environment
• Liaise with CRO’s, EDC vendors and other third-party vendors
• Monitor timelines and ensures that clinical data management deadlines are met with quality
• Support GCP inspection readiness
• Performs other duties as assigned

Required Qualifications:
• Prefer B.S. (or equivalent degree) in a scientific or allied health field and 4-6 years of relevant work experience in the Pharmaceutical Industry or CRO
• Demonstrated experience with Electronic Data Capture (EDC)
• Knowledge of clinical research, medical terminology/disease processes and clinical practice
• Strong interpersonal, communication, organization, critical thinking, and problem-solving skills; able to adapt to internal/external deadlines and oversee vendors
• Experience working with MSOffice Suite (Excel, Word, PowerPoint)

Preferred Qualifications:
• Experience with the implementation of industry standards (CDISC, CDASH, and SDTM)
• Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
• Highly motivated; detail and process oriented; welcomes challenge and responsibility; team-player and can achieve results in a fast paced and changing environment

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.

Close
Senior Analyst/Manager, Total Rewards and HRIS

Job #::03-209

Job Title: Senior Analyst/Manager, Total Rewards and HRIS

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

Position Summary:
We are seeking a Senior HR Operations Analyst to be responsible for the day-to-day administration of the Company’s compensation and benefits programs and HRIS system.

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

Key Responsibilities:
• Responsible for day-to-day administration of benefit programs, including responding to employee inquiries, maintaining benefits technologies, executing on benefit communication strategies and implementing new benefit programs, as needed.
• Facilitate the annual benefits open enrollment process, including active participation in plan design decisions, updating employee benefits self-service system with plan details and testing system functionality, responding to employee inquiries related to open enrollment and benefit decisions and facilitating all necessary post-enrollment activities.
• Responsible for managing the company-wide employee recognition program, including plan design, marketing and day-to-day administration
• Manage the new employee onboarding process, including day-one orientation program
• Support day-to-day HRIS administration such as daily HRIS data entry and end-user support
• Participate in the implementation of new HR technologies, as needed
• Manage participation in industry benefits and compensation surveys to collect and analyze competitive information
• May support aspects of compensation administration, including benchmarking, communication, and facilitation of the annual compensation review process
• Responsible for compliance with all federal and state benefit related reporting requirements
• Recommend process improvements to ensure continued data accuracy and ensure process scalability.
• Other project or tasks as assigned

Required Qualifications:
• Bachelor’s degree
• 5 years of compensation and benefits administration experience
• Prior experience in life sciences industry preferred
• Exceptional attention to detail
• Proven excellent customer service skills and ability to be flexible, a team player and interface professionally with all levels of internal and external customers
• Demonstrated outstanding organizational skills required; ability to effectively manage multiple priorities and adapt to changing priorities
• Excellent verbal and written communication skills coupled with a “can do” and “whatever it takes” attitude
• Prior administrative experience with HRIS technologies preferred
• Advanced experience and capability with Microsoft Office products, including Excel

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.

Close
Manager/Senior Manager, Strategic Outsourcing

Job #:02-244

Job Title: Manager/Senior Manager, Strategic Outsourcing

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:
• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

We are seeking a Manager/Senior Manager, Strategic Outsourcing to support all clinical outsourcing activities as well as other corporate sourcing activities as requested. The position will work cross-functionally with internal stakeholders such as Data Management, Biostatistics, Translational Medicine, Legal, and Finance. General responsibilities include working with teams to properly assess outsourcing opportunities and provide contractual negotiation support, performance monitoring and follow-up. The successful candidate must be hands-on and comfortable developing procedures, templates, and relationships and work with the Director to contribute to growth and future state of the organization.

This position will report to the Director, Strategic Outsourcing and be located in the Waltham, MA office.

Key Responsibilities:
• Support the outsourcing process and activities for Clinical Development.
• Manage contracting activities including the preparation, finalization, and administration of CDAs, MSAs, Service Agreements, Work Orders, Change Orders, and Amendments while minimizing risk across a broad scope of clinical / therapeutic outsourcing services.
• Assist and/or manage the identification and selection process of clinical vendors such as CROs, central labs, IRT, Imaging, ePRO, Safety vendors, etc.
• Work closely with Clinical Business Operations and Finance to assure the assumptions for studies are aligned between finance and clinical forecasting.
• Meet with clinical trial managers, functional managers, Legal, and QA as needed to ensure vendors are meeting expectations and review progress against contract.
• Create and maintain outsourcing/vendor oversight standards and templates.
• Contribute to the development of an established preferred clinical vendor list.

Required Qualifications:
• Bachelor’s degree with at least five to eight years of experience with a focus on developing and overseeing clinical budgets, and contracts with clinical outsourcing vendors in the pharmaceutical/biotech industry (an equivalent combination of experience and education may be considered)
• At least four years of direct clinical trial and/or vendor oversight experience required; experience negotiating, administering, extending, terminating, and re-negotiating contracts
• Excellent interpersonal, organizational and multi-tasking skills.
• Ability to interface with vendors, collaborators, all internal departments and all levels of management
• Understanding of Clinical/Drug Development; familiar with Regulatory Guidelines including ICH GCP.
• Previous experience working with clinical operations and finance is 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.

Close
Senior Operations Specialist, Translational Medicine

Job #: 02-245

Job Title: Senior Operations Specialist, Translational Medicine

Location: Waltham, Massachusetts

Role Summary:
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients. We have used our proprietary drug discovery platform to develop a diverse pipeline of drug candidates designed to improve outcomes for patients with cancer by enhancing the quality, rate and/or durability of their responses to treatment. We currently retain global development and commercialization rights to our drug candidates, including three programs in clinical development. Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered just outside Boston 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 and opportunity for personal and professional growth based on these key principles:

• providing a collaborative, energized and fun work environment where people are empowered and supported in the achievement of their career goals
• a diverse and multi-disciplinary workforce
• dedicated and talented people who are passionate about achieving excellence in all they do
• a work environment that allows you to balance your priorities
• above all else, a commitment to the patients we serve

We are seeking a Translational Medicine Operations Specialist to work across all programs, partnering primarily with colleagues in Clinical Development, Clinical Operations and Program Management to ensure robust clinical sample and vendor management is in compliance with protocols, regulatory guidance and project timelines. The TM Operation Specialist will be responsible and accountable for managing/overseeing the entire sample and vendor management process for assigned projects from acquisition through analysis and final disposition.

This position will report to the Head of Translational Medicine and be located in the Waltham, MA office.

Key Responsibilities:
• Work closely with Clinical Operations and Translational Medicine to coordinate and manage the sample collection for on-going and planned clinical trials that have translational medicine objectives in their design.
• Manage kit preparation, sample collection procedures, shipping requirements, analytical data collection/reporting.
• Ensure robust chain-of-custody for clinical trial specimens.
• Manage contracts (material transfer agreements) with academic institutions and/or commercial partners that provide bio-specimens as part of collaborative or service provider agreements.
• Ensure/verify that collaborators have appropriate documentation, process and procedures in place to ensure samples are collected according to ethical and legal standards (both prospective or retrospective sampling)
• Manage budget negotiations
• Provide clinical trial budget forecasts that relate to all aspects of sample management (acquisition, transport, storage, analysis)
• Develop knowledge/understanding of regional bio-specimen applicable regulations to help facilitate protocol approvals by global ethics committees.

Required Qualifications:
• BS or MS degree in science with a strong track record in bio-pharma industry working on clinical development projects and in cross-functional team environment
• 3-5+ years of experience in industry
• Must have CRO/Vendor management experience
• Experience with contract and budget development, negotiation, and management; vendor management; and data and sample management
• Knowledge of GCPs for global compliance
• Protocol development experience a plus
• Interpersonal skills required to communicate effectively with collaborators and cross functional teams.
• Highly motivated and enjoys working in a fast-paced, dynamic environment.
• Excellent writing skills.
• Strong project management skills.
• Strong organizational skills, ability to prioritize and handle competing priorities.
• Positive, flexible self-starter who thrives under pressure.
• Excellent judgement and problem-solving skills.

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.

Close
Recruiting Coordinator

Job #: 03-206

Job Title: Recruiting Coordinator

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 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.

Close
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.

Close
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.

Close
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.

Close
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.

Close
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.

Close
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.

Close