Senior Manager, Clinical Pharmacology

Company DescriptionDeciphera, a member of ONO, 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.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. Job DescriptionThe Role:The Senior Manager, Clinical Pharmacology, will be responsible and accountable for  executing 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 with cross-functional stakeholders including research, DMPK, toxicology, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.This position will report to the Director, Clinical Pharmacology, and work on-site at our Waltham, MA office. Deciphera expects a minimum number of three days a week on site, with flexibility as to hours on site on any given day to accommodate work/life balance. Specific days and times spent in the office should be determined in conjunction with your manager.What You’ll Do:Act as the lead clinical pharmacologist on clinical pharmacology study teams to support clinical development:  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.)Provide input and strategy recommendations as a clinical pharmacology subject matter expert for various development programs.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, 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, and exposure-response analyses in support of early clinical programs and regulatory submissions.QualificationsWhat You’ll Bring:Ph.D., Pharm.D., or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines with 1-3+ years of clinical pharmacology industry experience or M.S. with 5+ years of relevant experience.Hands-on experience with standard PK Software (e.g., Phoenix, R, Monolix). Experience and/or knowledge of M&S software to drive M&S activities (e.g., population PK and PK/PD, exposure-response, PBPK) is preferred.Strong understanding of clinical pharmacology concepts and conducting clinical pharmacology studies and knowledge of regulatory requirements related to clinical pharmacology, M&S, and drug development.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.Record of contribution to INDs, CTAs, CSRs, NDAs, and MAAs as well as experience with regulatory agency interactions is preferred. Previous experience in oncology indications is preferred.Additional InformationDeciphera offers a comprehensive benefits package that includes but is not limited to the following:Non-accrual paid time offSummer vacation bonusGlobal, company-wide summer and winter shutdownsAn annual lifestyle allowanceMonthly cell phone stipendInternal rewards and recognition programMedical, Dental, and Vision Insurance401(k) retirement plan with company matchLife and Supplemental life insurance for familyShort and Long Term Disability insuranceHealth savings account with company contributionFlexible spending account for either health care and/or dependent care.Family planning benefitGenerous parental leave[if applicable] Car allowanceDeciphera, a member of ONO, is a company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.EQUAL EMPLOYMENT OPPORTUNITY INFORMATIONDeciphera 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.SummaryType: Full-timeFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals