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 Pharm

D 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 Win Nonlin)
* 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 .
For additional benefits information, visit:
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