Senior Director, Clinical Pharmacology

This is a fully remote position, open to applicants in California.

📋 Description

• Formulate the 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.

• Work collaboratively with DMPK, clinical research, and CMC teams to establish the biopharmaceutics and clinical pharmacology studies necessary for supporting an NDA and drug labeling.

• Define the scope, design, plan, and analyze pharmacokinetic and pharmacodynamics studies for phases 1 through 4.

• Provide clinical pharmacology expertise to the project team while maintaining close collaboration with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.

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

• Take accountability 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 immediate/short-term (<2 Years) and long-term (5 years) strategic planning to establish functional objectives.

• Lead, direct, manage, develop, coach/mentor, and assess direct reports while 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 solid understanding of clinical pharmacology principles.

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

• A minimum of 10 years’ experience in a supervisory position.

• At least 13 years of overall professional experience is required.

• Knowledge of all phases of clinical drug development, including previous experience in drafting components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projects.

• Proven ability to independently create clinical pharmacology strategies and design studies to characterize PK and PK/PD relationships of clinical development compounds.

• Preferred expertise/experience in various clinical pharmacology areas such as 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 with successful outcomes from the filings.

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

• Proficient in using PK and PK/PD Modeling software tools like Phoenix.

• Excellent written, presentation, and verbal communication skills.

• A critical thinker with strong problem-solving capabilities.

• Ability to influence business leaders at all levels.

🏝️ Benefits

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401k matching.

• 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.

• Winter company shutdown.