Assoc Clinical Pharmacology Director

* As a member of a drug development team, routinely 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.* With input from others, designs clinical pharmacology study protocols, study data analysis, modeling and simulation plans.* 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.* May support business development / due diligence activities as a clinical pharmacology expert.* 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.* Doctorate and 5+ years of relevant experience OR* Master’s and 8+ years of relevant experience OR* Bachelor’s and 10+ years of relevant experience OR* PhD or PharmD in pharmaceutical sciences, pharmacology or related discipline* 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.Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans\*.

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