Associate Director, Clinical Pharmacology (Foster City, CA or Parsippany, NJ) β supporting drug development in Virology and Pediatrics.
Specific Job Responsibilities:
- Provide input into product development strategies and/or research/clinical development plans.
- Author the clinical pharmacology plan for one or more products.
- Lead and manage design and conduct of clinical pharmacology studies (increasing complexity), including cross-functional study team leadership.
- Design clinical pharmacology study protocols, study data analysis, modeling, and simulation plans.
- Lead study protocol review discussions (scientific/procedural aspects).
- Implement and monitor studies with cross-functional partners and study sites; address clinical issues.
- Direct activities/resources for internal and external study partners.
- Manage timelines and resources to ensure timely, accurate execution.
- Conduct PK-PD analyses; author clinical pharmacology inputs into study documentation and data analysis/management plans; contribute to scientific presentations/literature.
- Analyze/interpret and author documents for clinical and regulatory submissions.
- Present project updates/milestones to cross-functional partners and stakeholders.
- May support business development/due diligence.
- Represent clinical pharmacology with regulatory agencies.
- Anticipate trial problems and develop solutions.
- Ensure study conduct meets regulatory requirements, GCP, and Gilead SOPs.
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 verbal/written/interpersonal communication.
- Experience with PK analysis software (e.g., WinNonlin).
- Leading cross-functional teams; matrix management.
- Clinical pharmacology concept/protocol design and authoring development plans.
- Regulatory filing experience (strongly preferred).
- Clinical publications/presentations experience.
- Fast learner; flexible/adaptable; travel when needed.
- Thorough knowledge of FDA/EMA, ICH, and GCP; pharmaceutical regulatory requirements.
- Apply business acumen to strategic scientific projects.
People Leader Accountabilities:
- Create Inclusion, Develop Talent, Empower Teams.
Benefits/Compensation (as stated):
- Salary range: Bay Area $195,670β$253,220; Other US locations $177,905β$230,230.
- May be eligible for discretionary bonus and stock-based long-term incentives; paid time off; benefits include medical, dental, vision, and life insurance.
Application Instructions:
- Please apply via the Internal Career Opportunities portal in Workday.