Senior Director, Clinical Pharmacology

📋 Description

• Formulate a clinical pharmacology strategy and associated clinical development plan that aligns with the target product profile, program objectives, and US/international regulatory guidelines for small molecule therapeutics.

• Collaborate with DMPK, clinical research, and CMC teams to outline the biopharmaceutics and clinical pharmacology studies essential for supporting an NDA and drug label.

• Define the scope, design, planning, and analysis of phase 1-4 pharmacokinetic and pharmacodynamics studies.

• Provide clinical pharmacology expertise to the project team while working closely with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.

• Engage in the selection of Phase 1 CROs for clinical pharmacology studies.

• Be accountable for the analysis and interpretation of PK and PK/PD data.

• Contribute to the preparation of clinical study protocols and reports.

• Plan, prepare, and review the clinical pharmacology section of regulatory documents (IND, IMPD, IB, NDA CTD, etc.).

• Act as the primary Clinical Pharmacology Lead and actively participate in cross-functional teams to ensure the integration of contemporary clinical pharmacology principles into project plans and study designs.

• Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert.

• Focus on both short-term (<2 Years) and long-term (5 years) strategic planning to establish functional objectives.

• Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning.

⛳️ Requirements

• Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or a related field, with a robust understanding of clinical pharmacology principles.

• Over 10 years of substantial industry experience in the execution and/or oversight of clinical pharmacology functions, studies, and data analysis.

• At least 10 years of experience in a supervisory capacity.

• A minimum of 13 years of overall professional experience is required.

• Familiarity with all phases of clinical drug development, including previous experience in preparing components of the Clinical Pharmacology sections of regulatory submissions for IND- and NDA-stage projects.

• Proven capability to independently develop clinical pharmacology strategies and design studies that characterize PK and PK/PD relationships of clinical development compounds.

• Preferred expertise/experience in various clinical pharmacology areas, including FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special populations, and radiolabeled mass balance studies.

• Extensive experience in preparing INDs, CTAs, NDAs, and MAAs, along with successful outcomes from these filings.

• Experience in working within a cross-functional team/matrix environment with proficient vendor management skills.

• Proficient in utilizing PK and PK/PD modeling software tools such as Phoenix.

• Strong written, presentation, and verbal communication abilities.

• A critical thinker with exceptional problem-solving capabilities.

• Ability to influence business leaders at all levels.

🏝️ Benefits

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401k match.

• Comprehensive health insurance plans for employees (and their families), including medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Company-wide winter shutdown.