Senior Director, Clinical Pharmacology

Position Summary
- Senior Director, Clinical Pharmacology will develop clinical pharmacology strategy aligned to the target product profile (TPP) and clinical development plan (CDP), lead Phase 1 clinical pharmacology studies (design, execution, interpretation, reporting), and serve as clinical pharmacology lead on studies and project teams. Supports small molecule therapeutics for rare endocrine disorders and endocrine-related cancers.

Essential Job Functions and Responsibilities
- Develop clinical pharmacology strategy and related clinical development plan consistent with TPP, program goals, and US/international regulatory guidance.
- Collaborate with DMPK, Clinical Research, and CMC to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label.
- Determine scope, design, plan, and analyze Phase 1–4 pharmacokinetic (PK) and pharmacodynamic (PD) studies; develop population PK models and required PK/PD analyses for regulatory and development needs.
- Provide clinical pharmacology expertise; collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.
- Contribute to Phase 1 study design (e.g., drug-drug interactions, relative bioavailability/bioequivalence, special populations, thorough QT).
- Participate in selection of Phase 1 CROs.
- Analyze and interpret PK and PK/PD data.
- Participate in preparation of clinical study protocols and reports.
- Plan, prepare, and review clinical pharmacology sections of regulatory documents (IND, IMPD, IB, NDA CTD); draft publications and make scientific presentations.
- Serve as primary Clinical Pharmacology Lead and integrate modern clinical pharmacology principles into project plans and study design.
- Represent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expert.
- Lead long-term and short-term (current and 5-year) strategic planning; lead/direct/manage/mentor/evaluate direct reports and contribute to budget and headcount planning.

Required Qualifications
- Pharm.D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with strong understanding of clinical pharmacology.
- 10+ years industry experience in conduct and/or oversight of clinical pharmacology studies/data analysis; minimum 10 years in a supervisory role (13 years total professional experience required).
- Familiarity with all stages of clinical drug development, including preparation of Clinical Pharmacology sections for IND- and NDA-stage regulatory submissions.
- Demonstrated ability to independently develop clinical pharmacology strategy and design studies characterizing PK/PK/PD relationships.
- Expertise/experience in multiple clinical pharmacology areas (FIH and/or Phase II/III dose selection, pediatric dose selection, drug-drug interactions, drug metabolism enzymology, formulation bridging, bioequivalence, food-effect, exposure-QTc, special populations, radiolabeled mass balance).
- Extensive experience preparing INDs, CTAs, NDAs, and MAAs with successful filing outcomes.
- Cross-functional/matrix experience with strong vendor management skills.
- Proficiency with PK/PK-PD modeling tools such as Phoenix.
- Strong written, verbal, and presentation communication skills.
- Critical thinking/problem-solving skills; ability to influence business leaders at all levels.

Preferred Qualifications
- Population PK and exposure-response analysis experience (plus).

Benefits (if applicable)
- Discretionary annual target bonus; stock options; ESPP; 401k match.
- Medical, dental, vision, basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.

Travel/Work Environment (if applicable)
- Travel up to 5% of the time.