Associate Director, Clinical Pharmacology (Virology, Pediatrics) β Foster City, CA or Parsippany, NJ.
Specific Job Responsibilities:
- Provide input to product development strategies and/or research/clinical development plans.
- Author clinical pharmacology plans.
- Lead and manage design and conduct of clinical pharmacology studies; lead cross-functional study teams.
- Design study protocols and analysis/modeling & simulation plans.
- Lead protocol review discussions.
- Implement/monitor studies with partners and sites; address pharmacology study issues.
- Direct activities/resources for internal and external partners; manage timelines/resources.
- Conduct PK-PD and related analyses; author study documentation, data analysis/management plans, and scientific presentations/literature.
- Analyze and author documents for clinical and regulatory submissions.
- Present project updates/milestones to stakeholders.
- May support business development/due diligence; represent clinical pharmacology with regulatory agencies.
- Anticipate trial problems and develop solutions; ensure GCP/regulatory/SOP adherence.
Basic Qualifications:
- Bachelorβs + 10 years OR Masterβs + 8 years OR PhD/PharmD + 5 years.
Preferred Qualifications / Skills:
- PhD or PharmD in pharmaceutical sciences/pharmacology (or related).
- Strong communication; experience with WinNonlin or similar PK software.
- Lead cross-functional teams; matrix deliverables.
- Clinical pharmacology concept/protocol design and development plan authoring.
- Strong knowledge of FDA/EMA/ICH/GCP and clinical pharmacology regulatory requirements.
- Regulatory filings, publications/presentations; fast learner; adaptable; travel when needed.
People Leader Accountabilities:
- Create inclusion; develop talent; empower teams.
Compensation/Benefits (as stated): Bay Area $195,670β$253,220; Other US $177,905β$230,230. Eligible for discretionary bonus and long-term incentives; paid time off; company-sponsored medical/dental/vision/life insurance.
Application instruction:
- Please apply via the Internal Career Opportunities portal in Workday.