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Associate Director, Clinical Pharmacology
3 months ago
Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera's switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
Job Description
The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
This position will report to Director, Clinical Pharmacology, and be located in the Waltham office or may be remote.
Key Responsibilities:
- Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development: independently lead the design, protocol development, execution, analysis, and reporting of clinical pharmacology studies (e.g., food effect, BA/BE, human ADME, drug interactions, renal and hepatic impairment, etc.)
- Represent the department as subject matter expert on cross-functional project teams and be able to influence team strategy.
- Author and review relevant sections of clinical study protocols, analysis plans, study reports, and regulatory submissions.
- Contribute to regulatory submissions and health authority agency interactions relevant to clinical pharmacology including but not limited to pre-meeting briefing packages, INDs, IBs, queries and information requests, 2.7.1 & 2.7.2 modules and label discussions.
- Independently plan and conduct hands-on analyses, including NCA, population PK and PK/PD analyses, exposure-response analyses, PBPK analyses, to answer development questions and to inform clinical development strategy.
- Develop and maintain collaborative relationship with colleagues within the department, internal stake holders (i.e., DMPK, toxicology, biology, translational medicine, medical, clinical, biometrics, regulatory, clinical operations, CMC, etc.) and external vendors.
- Manage external vendors to perform PK, PBPK, population PK and PK/PD, exposure-response analyses in support of early clinical programs and regulatory submissions.
- Ph.D., Pharm.D. or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 5 years of clinical pharmacology industry experience or M.S. with 10 years of relevant experience.
- Leadership potential, effective and clear written and verbal communication, problem solving, and presentation skills are essential for the role.
- Strong project management skills and ability to prioritize and manage multiple projects simultaneously.
- Strong understanding of clinical pharmacology concepts and proficiency in conducting clinical pharmacology studies.
- knowledge of regulatory requirements related to clinical pharmacology, M&S, and drug development and record of contribution to INDs, CTAs, CSRs, NDAs, and MAAs as well as experience with regulatory agency interactions.
- Hands-on experience with standard PK and M&S software (e.g., Phoenix, NONMEM, R, Monolix, MATLAB) to drive M&S activities (e.g., population PK and PK/PD, exposure-response, PBPK)
- Previous experience in oncology indications is preferred.
- Demonstrated ability to work effectively and collaboratively on cross-functional teams.
We offer an outstanding culture and opportunity for personal and professional growth guided by our "PATHS" Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune's Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
Deciphera offers a comprehensive benefits package that includes but is not limited to the following:
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Monthly cell phone stipend
- Internal rewards and recognition program
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- ESPP offering
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
- [if applicable] Car allowance
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.
