Associate Clinical Pharmacology Director

Associate Director, Clinical Pharmacology (Foster City, CA or Parsippany, NJ) supporting drug development in Virology and Pediatrics.

Specific Job Responsibilities
- Provide input into product development strategies and/or research or clinical development plans for assigned products/projects.
- Author the clinical pharmacology plan for one or more products in the assigned disease/therapeutic area.
- Lead and manage the design and conduct of clinical pharmacology studies (increasing complexity), including leading cross-functional study teams.
- Design clinical pharmacology study protocols and study data analysis/modeling/simulation plans.
- Lead study protocol review discussions (scientific and procedural aspects).
- Work with cross-functional partners and study sites to implement and monitor studies; address arising clinical issues.
- Direct activities and resources for internal and external study partners.
- Manage study timelines and resources to ensure timely, accurate execution.
- Conduct PK-PD and related analyses; author or contribute to study documentation, data analysis/management plans, and scientific presentations/literature.
- Analyze, interpret, and author documents for clinical and regulatory submissions.
- Present project updates and key milestone information to partners and stakeholders.
- May support business development/due diligence as a clinical pharmacology expert.
- Represent clinical pharmacology with regulatory agencies.
- Anticipate clinical trial problems and develop solutions using precedents and original thinking.
- Adhere to regulatory requirements, Good Clinical Practice (GCP), and Gilead SOPs.

Basic Qualifications
- Bachelor’s degree and 10 years’ experience
OR
- Master’s degree and 8 years’ experience
OR
- PhD/PharmD and 5 years’ experience

Preferred Qualifications / Required Skills
- PhD or PharmD in pharmaceutical sciences, pharmacology, or related discipline.
- Excellent verbal, written, and interpersonal communication skills; ability to convey complex technical information.
- Experience with pharmacokinetic program/analysis software (e.g., WinNonlin).
- Experience leading small cross-functional teams and managing via matrix management.
- Significant experience in clinical pharmacology study concept/protocol design and authoring development plans.
- Strongly preferred: experience contributing to regulatory filings.
- Experience supporting clinical publications and presentations.
- Ability to be a fast learner; flexible/adaptable to change.
- Thorough knowledge of FDA/EMA regulations, ICH guidelines, and GCP; significant knowledge of pharmaceutical regulatory requirements for clinical pharmacology.
- Ability to apply business acumen to strategic scientific projects.
- When needed, ability to travel.

People Leader Accountabilities
- Create Inclusion; Develop Talent; Empower Teams.

Benefits
- May be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and benefits package including company-sponsored medical, dental, vision, and life insurance.

Application Instructions
- Please apply via the Internal Career Opportunities portal in Workday (for current employees/contractors).