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

Information Technology Manager

Job #: 02-220

Job Title: Information Technology 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 an Information Technology Manager to provide technical and hands-on leadership. A successful manager would be a fast learner that can understand the company’s operations to provide support and expand services. We are looking for a hands-on manager that can assist in various projects as well as providing technical feedback for the team members.

This position will report directly to the Director of Information Technology.

Key Responsibilities:

    • Manage IT’s operations and projects, such as:
      • Windows Server provisioning, virtualization (Hyper-V) and hardening.
      • Network design and management using Cisco hardware.
      • Workstation provisioning of Windows 10 and macOS 10.13 systems, along with troubleshooting and support.
      • Support DR and continuity design and implementation, along with archiving data.
      • Performance and security monitoring implementation.
    • Manage and participate in IT’s response to issues and alerts.
    • Maintain and evaluate hardware needs and supplies.
    • Knowledge of change control implementation and documentation.
    • Work with consultants, vendors, and auditors to satisfy security requirements

Experience and Required Skills

    • Bachelor’s degree in Computer Science or related field.
    • 5+ years IT experience in enterprise and server environments.
    • Senior level experience with macOS 10.12 and higher.
    • Strong experience supporting enterprise grade servers running Microsoft Server 2016, 2012 and/or 2008 and services including: Active Directory, Group Policy, Oracle, WSUS, printer queues and network monitoring platforms.
    • Strong software proficiency with Microsoft Word, Excel, PowerPoint, and other desktop applications.
    • Good experience with enterprise grade firewalls and switches.
    • Good experience with security audited environment.
    • Evaluate new technologies that relate to the IT strategy.

 Additional Skills/Preferences

    • MCSA certification or higher, in either Windows Server, Windows 10, Office 365 or Cloud Platform.
    • Proven experience with layer 1, layer 2 and layer 3 Ethernet networking concepts.
    • Provide training and educational opportunities for new IT services and trends to employees.
    • Pharmaceutical or scientific knowledge to help evaluate and expand clinical services.
    • Strong organizational skills to help maintain current IT projects and progress.
    • Excellent verbal and written communication skills.
    • Strong interpersonal skills to establish a good working relationship with colleagues, while maintaining professional standards.
    • Ability to work with minimal supervision.

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 care.

Close
Clinical Project Manager

Job #:  02-223

Job Title:   Clinical Project Manager (CPM)

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 Clinical Project Manager to manage clinical trials from initiation to completion through leading internal and external cross-functional disciplines.

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

Key Responsibilities:

    • 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
    • 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 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO
    • 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, project)
    • Ability to travel approximately 20%

 Preferred Qualifications:

    • Bachelor’s degree in health profession and/or science
    • A minimum of 3-4 years of relevant clinical operations experience in the pharmaceutical industry (oncology 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
Clinical Trial Associate

Job #:  02-224

Job Title:   Clinical Trial Associate (CTA)

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 Clinical Trial Associate (CTA) to assist and provide support to the members of the clinical operations project team in order to facilitate the management of the clinical trial processes, including planning and execution of clinical trials. The Clinical Trial Associate (CTA) assists in supporting the conduct of trials and may be responsible for managing specific study and operational tasks. The CTA performs work within established protocols under general supervision

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

Key Responsibilities:

    • Prepare EDC reports (e.g. CRF completion, SDV, query reports) for CPMs
    • Maintain study enrollment / patient visit trackers
    • Schedule meetings, prepare meeting agendas, and author/distribute meeting minutes
    • Maintain study contact lists
    • May be responsible to ensure Clinicaltrials.gov is updated accordingly
    • Update financial study visit trackers
    • Compare investigative site invoices to clinical database
    • Organize / maintain cloud study folders
    • Track monitoring visit schedule and review monitoring visit reports and site follow-up letters
    • Provides input and coordinates the delivery of clinical trial supplies in collaboration with the clinical supply team
    • Track investigational site and vendor budgets and payments
    • Assist study team with preparation for audits/inspections
    • Assist in creating, editing, and distributing informed consent templates, patient registration forms, letters, reports, manuals and other study documents
    • Support site start-up activities
    • May review background and assess feasibility information of potential new sites
    • May facilitate CDAs
    • Ensure that all study files and documents are accurate, current and complete
    • Perform essential document collection, review, maintenance and close-out activities, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements, ICH/GCP guidelines and SOPs
    • Track submission to and approval from IRBs, 1572 changes (including obtaining medical licenses and CVs related to these changes), site personnel changes
    • Maintain study FAQ list
    • Assist with resolution of investigational site/data queries
    • Up to 10% domestic and/or international travel may be required to sites and meetings
    • Liaise with project team members regarding study site issues
    • May provide study-specific training and mentoring to CRAs and site staff
    • Perform quality control review of documents and presentations

Required Qualifications:

    • Bachelor’s degree
    • Excellent communication (oral and written), organizational, and problem solving skills
    • Excellent Microsoft Office skills
    • High energy individual able to effectively multi-task and strive in a dynamic start-up environment
    • Strong attention to detail
    • 2 years of hands on clinical research experience either at an academic center, CRO or Pharmaceutical/Biotech company.

Preferred Qualifications:

    • 2–4 years of relevant hands-on drug experience in CRO or sponsor setting

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, Data Management

Job #:  02-221

Job Title:   Manager, Data 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 Manager, Data Management to oversee the quality of outsourced Data Management activities for Oncology Clinical Trials ranging from Phases I to III.

This position will report to the Associate Director of Data Management and be located in the Waltham, MA office.

 Key Responsibilities:

    • Act as the DM subject matter expert for process related questions from CROs, third party vendors and cross functional areas
    • May simultaneously act as lead Data Manager for multiple clinical trials from study start up through database lock
    • Participate in User Acceptance Testing for clinical database, randomization database and ePRO devices
    • Review study documentation to ensure appropriate quality
    • Assist with development of therapeutic area standards for Case Report Forms and Edit Checks
    • Oversee submission of documents to Trial Master File and related QC
    • Ensure study documentation is inspection ready
    • Assist Site Monitors with data entry and query resolution support
    • Review coding and SAE reports on an ongoing basis
    • Work with Medical Affairs team to arrange timelines for delivery of data for posters and presentations
    • Present ongoing study updates to management
    • Manage escalation of study-related issues and communicate as appropriate with management
    • Help select and manage data related clinical trial vendors such as CROs and external laboratories, and ensure their performance is consistent with Deciphera standards
    • Oversee quality of both clinical and external data sources
    • Lead cross-functional team in ongoing data review
    • Work closely with biostatistician and programmers to ensure plans for data mapping and analysis are defined and appropriately documented
    • Oversee the authoring and management of study-related documentation (e. g. Data Management Plan, external vendor handling guidelines, Case Report Form Completion Guidelines, Coding Plan, etc.)
    • Assist with the development of Data Management related procedures and work instructions as necessary
    • Monitor the status of clinical data collection and query trends
    • Assess study risks and develop risk mitigation strategy with cross-functional team members

 

Required Qualifications:

    • Bachelor’s degree in health profession and/or science
    • A minimum of 8 years of Data Management experience in the pharmaceutical industry
    • Knowledge of the clinical trial process, ICH GCP, GCDMP and applicable health authority regulations
    • Excellent verbal and written communications skills
    • Proficiency in Electronic Data Capture systems
    • Self-motivated, with strong organizational skills and attention to detail
    • Computer proficiency in MS Office (i.e. Word, Excel, PowerPoint)

Preferred Qualifications:

    • Working knowledge of CDISC and SDTM standards
    • Ability to solve complex problems in a fast-paced environment, providing risk mitigation and solutions
    • Minimum of two years’ experience in Oncology trials
    • Proficiency in IBM Clinical Development

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
Associate Director/Director Clinical Scientist

Job #:02-222.pdf

Location: Waltham, MA

Role Summary:

Deciphera Pharmaceuticals, a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, is seeking an Associate Director/Director – Clinical Scientist with experience in managing multidisciplinary drug development projectsThe successful candidate will interact within a multi-disciplinary, matrix work group ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans.  The Clinical Scientist will be involved in operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications.

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, 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

Basic Qualifications:

    • MS in Life Sciences (or BS plus equivalent experience); Pham 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

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 care.

Close
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.

Close
Senior Director Biostatistics and Data Management

Job #: 02-217

Job Title: Senior Director of Biostatistics and Data 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 Director for Biostatistics and Data Management who will manage the statistical and data management department including statistical regulatory strategies for Oncology clinical trials and regulatory submissions. This position requires experience in: applying theoretical statistical methodologies to clinical research datasets; protocol design; writing statistical analysis plans; facile ability with computing software (e.g., SAS, R); data management, a general understanding of worldwide regulatory requirements, and clinical trial expertise from all phases of Oncology drug development. Experience with preparing regulatory briefing documents and worldwide regulatory submissions are also required. This position involves participation on project teams and interactions with Contract Research Organizations (CROs), Clinical Research, Data Management, Clinical Scientists, Translational Medicine and Regulatory Affairs staffs to coordinate the statistical activities associated with Oncology drug development projects.

This position will report directly to the VP of Clinical Development and Translational Research.

Basic Qualifications:

    • Experience in the statistical planning, study design, analysis, reporting and communication of data, and analyses of clinical studies from all phases of clinical development and post-approval
    • Thorough understanding of statistical principles and clinical trial methodology with the ability to independently practice and implement them, and the ability to provide solutions to a variety of technical problems of wide ranging scope and complexity
    • Ability to handle a large volume of highly complex tasks with little to no supervision
    • Proficiency and experience in SAS programming, and detailed knowledge of SAS procedures and other statistical software
    • Excellent analytical, problem solving, communication and organization skills with the ability to work simultaneously on multiple tasks and teams
    • Flexibility to deal with multiple priorities, detail-oriented, ability to work well under pressure in a collaborative environment, and a drive to learn and improve skills
    • Excellent written and oral communication skills including grammatical/technical writing skills
    • Effective team player: willingness to go the extra distance to get results, meet deadlines, etc.
    • Able to be flexible when priorities change; able to deal with ambiguity
    • Knowledge of medical/biological terminology in Hematology/Oncology

Preferred Qualifications:

    • PhD (preferred; minimum 15 years of experience) in Statistics/Biostatistics in the biopharmaceutical industry, with knowledge of biomedical sciences.
    • Demonstrated expertise in statistical planning, data analysis and reporting of clinical trial data is a must.
    • Detailed knowledge of statistical regulatory requirements/regulations and currently acceptable statistical methodologies also required.
    • Solid, hands-on knowledge of the use of statistical software (e.g., SAS or SAS Jump), including report generation is necessary.
    • Strong MS Office skills (Word, Excel, PowerPoint), and skills in generating graphs and figures.
    • Excellent verbal and written communication and interpersonal skills.
    • Demonstrated ability to work in a team environment
    • High degree of motivation; results oriented.

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
Scientist/Senior Scientist, Translational Medicine

Job #:  02-210

Job Title:  Scientist/Senior Scientist, Translational Medicine

Role Summary:

Deciphera Pharmaceuticals, a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, is seeking a scientist/Sr. Scientist, Translational Medicine. The candidate will work in the clinical team to provide translational medicine support to project needs.

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

Key Responsibilities:

    • Define pharmacodynamic markers related the mechanism of action of the drug in clinical development.
    • Design biomarker clinical studies to test novel hypothesis on drug MOA, identify immune response/tumor related biomarkers and patient population susceptible to respond to novel agents in oncology.
    • Develop collaborative studies with external investigators from academic centers, hospitals or technological expert companies.
    • Identify and maintain close relationship with CROs in outsourcing biomarker analysis of clinical trial samples.
    • Work closely with Trial Operation in setting up logistics, tracking sample, performing data analysis and data transfer for statistical analyses.
    • Responsible for authoring biomarker sections of clinical trial related documents including IB, IND, CSR, as well as regulatory submission.
    • Commit to help the team achieve deliverables and meet aggressive timelines.

 Qualifications:

    • A Ph.D. in molecular biology, immunology or other related life science disciplines with at least 3 years of postdoctoral training in clinical oncology drug development and biomarkers setting.
    • Strong scientific background and solid understanding of tumor microenvironment and  immuno-Oncology.
    • Ability to identify / follow cutting edge research to develop innovative approaches.
    • Ability to work in a cross functional and team environment with internal and external collaborators.
    • Experience in managing and outsourcing to CROs and vendors
    • Experience in clinical sample management.
    • Effectively communication with internal and external key stakeholders

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/Associate Director CMC, Small Molecule Manufacturing

Job #: 02-214

Job Title: Director/Associate Director CMC, Small Molecule Manufacturing

Location: Lawrence, KS

Summary  

Deciphera Pharmaceuticals is looking for a Director/Associate Director, CMC to join our Lawrence, KS facility.  Working collaboratively with senior CMC management and clinical development teams, the Director/Associate Director will be responsible for ensuring timely delivery of active pharmaceutical ingredients (API) in support of IND enabling programs and ongoing clinical development programs. The CMC Director will further provide written support for regulatory CMC filings. This individual will work collaboratively with other internal and external Pharmaceutical Sciences and Regulatory personnel on appropriate CMC-related reports and filings.

Key Responsibilities

  • Design and implement phase appropriate API supply strategies to support clinical programs at various stages.
  • Manage CMOs/CROs in conduct of API process development, process optimization, scale-up and clinical manufacturing.
  • Provide critical pre- and post-review of manufacturing batch records and integrate results into CMC regulatory filings.
  • Author and review regulatory reports/documents such as IND filings, IND updates, product development reports, quality summary, master batch records and other key reports/documents.
  • Work with CMC senior leadership to create and communicate project strategy, plans and schedules that are aligned with company objectives and portfolio prioritization.
  • Communicate project status to project leaders to assist in driving decision making.

Experience and Required Skills

  • PhD or MS degree in Chemistry or Chemical Engineering, and at least 10 years of hands-on experience in small molecule drug development.
  • Strong understanding of Organic synthesis and ability to direct and guide the work of CMOs.
  • Understanding of cGMP manufacturing.
  • Prior project management experience.
  • Late stage development and commercialization experience is a plus.

Additional Skills/Preferences

  • Familiarity with US and international regulatory CMC guidance and processes
  • Prior experience filing INDs and NDAs highly desirable
  • Strong team player with excellent written and verbal communication skills
  • Excellent computer skills (e.g., Microsoft Office, Excel, Project)
  • Strong organizational skills with attention to detail and ability to manage multiple projects at once
  • Ability to work both independently and in a team focused environment
  • Limited travel may be required (less than 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 health care and/or dependent care.

Close
Project Manager, CMC (Chemistry, Manufacturing and Controls)

Job #: 02-215

Job Title: Project Manager, CMC (Chemistry, Manufacturing and Controls)

Location: Lawrence, KS

Summary  

Deciphera Pharmaceuticals is seeking a project manager to join our Lawrence, KS facility.  Working collaboratively with CMC directors and senior management, the Project Manager will be responsible for ensuring timely execution of CMC deliverables in support of IND enabling programs and ongoing clinical development programs.  The Project manager will support contracts for both drug substance and drug product manufacturing.  This individual will provide written support for regulatory CMC filings.

Key Responsibilities

    • Manage contracts with CMOs/CROs conducting development work or manufacturing of API and drug product in support of Deciphera clinical stage programs.
    • Liaison between CMOs/CROs and Deciphera Finance department.
    • Monitor stability programs for Drug Substance and Drug Product and assist in preparation of regulatory documents.
    • Work with CMC senior leadership to create and communicate project plans and timing.

 Experience and Required Skills

    • BS degree in Chemistry, Chemical Engineering or Pharmaceutical Sciences, and at least 7 years of hands-on experience in management of drug development activities. Advanced degree preferred
    • Familiarity with cGMP manufacturing.
    • Excellent written and verbal communication skills.
    • Excellent computer skills (e.g., Microsoft Office, Excel, Project).
    • Strong organizational skills with attention to detail and ability to manage multiple projects at once.

Additional Skills/Preferences

    • Familiarity with US and international regulatory CMC guidance and processes highly desirable.
    • Ability to work both independently and in a team focused environment.
    • Limited travel may be required (less than 10%).

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 care.

Close

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.