Senior Manager, Clinical Pharmacology Lead

6 days ago


Waltham, Massachusetts, United States Deciphera Pharmaceuticals Full time
Unlock Career Growth in a Thriving Biopharmaceutical Company

We are Deciphera Pharmaceuticals, a leading biotech firm dedicated to revolutionizing cancer treatment through innovative medicines. Our team is passionate about making a difference in the lives of patients and families affected by this disease.

About the Role:

We seek a Senior Manager, Clinical Pharmacology, to join our talented team in Waltham, Massachusetts. This dynamic position will play a pivotal role in executing clinical pharmacology strategies and activities for assigned programs and studies. As a key member of our cross-functional team, you will collaborate with research, DMPK, toxicology, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management teams to ensure seamless project execution.

Key Responsibilities:

  • Design, develop, and execute clinical pharmacology studies, including food effect, bioavailability/bioequivalence, human ADME, drug interactions, renal and hepatic impairment studies.
  • Provide expert input and strategic recommendations on various development programs as a clinical pharmacology subject matter expert.
  • 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 related to clinical pharmacology.
  • Plan and conduct hands-on analyses, including non-compartmental analysis (NCA), to answer development questions and inform clinical development strategy.
  • Maintain collaborative relationships with colleagues within the department, internal stakeholders, and external vendors.

What We Offer:

We provide a comprehensive benefits package, including paid time off, summer vacation bonus, global company-wide 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, short and long-term disability insurance, health savings account with company contribution, flexible spending account for healthcare and/or dependent care, family planning benefit, and generous parental leave.

Requirements:

  • 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 modeling and simulation 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 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.

Location:

This position is based in Waltham, Massachusetts, with flexibility to work remotely. We offer a competitive salary range of $120,000 - $180,000 per annum, commensurate with experience.



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