Director, Clinical Pharmacology Lead
About The Position
As the Clinical Pharmacology Lead you will provide strategic leadership for Clinical Pharmacology activities across the West Coast Hub (WCH) Transplant portfolio, with primary accountability for Clinical Pharmacology strategy, execution, and regulatory deliverables supporting late-stage development and registration activities. This role will serve as the Clinical Pharmacology Lead for transplant programs, including leadership of Clinical Pharmacology activities supporting BLA submissions, regulatory interactions, labeling strategy, and lifecycle management. The successful candidate will be expected to operate independently, influence program-level decisions, and provide Clinical Pharmacology leadership for high-priority development programs. Candidates with hands-on experience leading the Clinical Pharmacology components of at least one major marketing application, such as a BLA or NDA, through filing preparation, health authority review, responses to information requests, and approval-stage interactions are strongly preferred. Reporting to the Head of Clinical Pharmacology and Pharmacometrics, WCH, this role will work closely with Pharmacometrics, Biomarkers, Clinical Development, Regulatory, Biostatistics, and other cross-functional partners to ensure Clinical Pharmacology strategies are scientifically rigorous, regulatory defensible, and aligned with overall program objectives.
Requirements
- PhD, PharmD, MD, or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics, Clinical Pharmacology, or a related discipline.
- 8+ years of relevant industry experience, including substantial experience supporting late-stage development, regulatory submissions, and health authority interactions.
- Demonstrated experience serving as a Clinical Pharmacology Lead for development programs with accountability for strategy and execution.
- Proven track record authoring and defending Clinical Pharmacology sections of BLAs, NDAs, supplemental applications, or equivalent regulatory submissions.
- Experience leading Clinical Pharmacology strategy for registration-enabling programs and supporting regulatory agency interactions.
- Deep expertise in dose justification, exposure-response evaluation, immunogenicity assessments, and Model-Informed Drug Development approaches.
- Strong knowledge of Clinical Pharmacology regulatory guidance and expectations for biologic products.
- Experience in transplant, nephrology, immunology, or related therapeutic areas.
- Ability to influence cross-functional teams and drive strategic decisions in a matrix environment.
- Excellent written, verbal, presentation, and interpersonal skills.
Nice To Haves
- Candidates with hands-on experience leading the Clinical Pharmacology components of at least one major marketing application, such as a BLA or NDA, through filing preparation, health authority review, responses to information requests, and approval-stage interactions are strongly preferred.
Responsibilities
- Represent Clinical Pharmacology on program and study teams as well as in governance forums, influencing key program decisions, contributing to the strategic direction of the Clinical Pharmacology function beyond transplant portfolio.
- Develop and execute integrated Clinical Pharmacology strategies that support dose selection and justification, benefit-risk assessment, regulatory approval, and lifecycle management.
- Lead preparation of Clinical Pharmacology components of major regulatory submissions, including BLAs, supplemental filings, briefing packages, information requests, and regulatory responses.
- Provide strategic leadership for regulatory interactions and represent Clinical Pharmacology in meetings with health authorities.
- Drive Clinical Pharmacology contributions to filing readiness activities and proactively identify and mitigate regulatory risks.
- Lead and oversee Clinical Pharmacology analyses, including exposure-responses assessments, population PK analyses, intrinsic and extrinsic factor evaluations, immunogenicity impact assessments, and Model-Informed Drug Development approaches.
- Partner closely with Pharmacometrics and other quantitative functions to ensure analyses support regulatory and development objectives.
- Provide mentorship and technical leadership within the Clinical Pharmacology function and contribute to the advancement of Clinical Pharmacology capabilities across WCH Development as well as providing scientific and strategic leadership that influences broader organization.
- Maintain expertise in evolving Clinical Pharmacology science, regulatory expectations, and development precedents relevant to transplant and immunology programs.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Education Level
Ph.D. or professional degree
