Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
About the role
- Associate Director, Clinical Pharmacology at Gilead managing drug development in Virology and Pediatrics therapeutic areas. Leading cross-functional study teams and authoring clinical pharmacology plans.
Responsibilities
- Provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
- Authors the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
- Leads and manages design and conduct of clinical pharmacology studies of increasing complexity, which includes responsibilities for leading the respective cross-functional study team.
- Designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans with input from others.
- Leads study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
- Works with cross-functional partners and study sites to implement and monitor clinical pharmacology studies.
- Addresses clinical issues arising from clinical pharmacology studies.
- Directs the activities and resources for both internal and external study partners.
- Manages study timelines and resources to ensure timely and accurate execution of clinical pharmacology studies.
- Conducts PK-PD and related analyses and provides clinical pharmacology input into or otherwise authors study documentation, data analysis / management plans and scientific presentations or literature.
- Analyzes, interprets and authors documents for clinical and regulatory submissions.
- Presents project updates and other key milestone information to cross-functional partners and stakeholders.
- Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies.
- Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking.
- Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
Requirements
- Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Five Years' Experience
- Excellent verbal, written, and interpersonal communication skills and ability to convey complex technical information clearly to others are required.
- Experience using pharmacokinetic program and analysis software (such as WinNonlin)
- Experience leading small cross-functional project teams and managing clinical project deliverables through matrix management
- Significant experience leading clinical pharmacology study concept and protocol design, authoring clinical pharmacology development plans.
- Experience contributing to regulatory filings is strongly preferred.
- Experience supporting clinical publications and presentations
- Demonstrate ability to be a fast learner.
- Demonstrate ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing the conduct of clinical studies.
- Has significant knowledge of pharmaceutical regulatory requirements related to clinical pharmacology.
- Demonstrate ability to effectively apply business acumen to strategic scientific projects.
- When needed, ability to travel.
Benefits
- Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role).
- Paid time off
- Company-sponsored medical, dental, vision, and life insurance plans.
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