Principal Scientist I, Clinical Pharmacology

Principal Scientist I, Clinical Pharmacology
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions. Making an impact on a global scale
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Job Description Principal Scientist I, Clinical Pharmacology: *This position is site based in Foster City, CA POSITION OVERVIEW:
You will typically lead multiple complex clinical pharmacology studies in [Enter TA or DA], which range from first-in human through approval and post-marketing activities. Working in collaboration with others, you are responsible for various aspects of clinical pharmacology program activities. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical pharmacology study start-up/execution/close out, PK-PD and related analysis, interpretation and reporting, and support of regulatory filings. You will lead multiple clinical pharmacology cross-functional study sub-teams, which entails coordinating and providing direction to internal and external partners involved in clinical pharmacology study design and execution. You will champion model-based drug discovery and development and serve as a clinical pharmacology specialist to cross-functional partners. You will also play a leadership role in developing and implementing new clinical pharmacology approaches that can bring impact and value to multiple programs. EXAMPLE RESPONSIBILITIES: 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 multiple complex clinical pharmacology studies, which includes responsibilities for leading the respective cross-functional study team. Typically owns a portfolio of clinical pharmacology studies/ projects / programs in the assigned disease or therapeutic area. 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. Anticipates problems that may arise in clinical trials and develops solutions for these using precedents and original thinking. Develops and implements new clinical pharmacology approaches that can bring benefit to multiple programs and teams. Represents clinical pharmacology for the assigned project team in interactions with regulatory agencies. Typically supports business development / due diligence activities as a clinical pharmacology expert. Develops thought leader and other external relationships that can guide short- and long-range R&D strategies and direction for assigned products. Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs. REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role. Minimum Education & Experience MD with 4+ years' relevant research or clinical experience in the biopharma industry, healthcare, consulting, academia or a related environment. Board certification in [Enter medical discipline] is preferred, including familiarity with clinical [Enter medical discipline] medicine. PharmD or PhD in pharmaceutical sciences, pharmacology or related discipline with 8+ years' relevant research or clinical experience. MS in pharmaceutical sciences, pharmacology or related discipline with 10+ years' relevant research or clinical experience. BS in pharmaceutical sciences, pharmacology or related discipline with 12+ years' relevant research or clinical experience. Significant experience working on, with and leading cross-functional project/program teams in life sciences. Extensive experience leading and authoring clinical pharmacology plans and modeling and simulation plans and having responsibility for the scientific execution and conducting of PK-PD, Pop PK-PD and related analyses across Phase I - IV studies. Extensive experience contributing to literature and regulatory submissions. Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership. Knowledge & Other Requirements Demonstrated ability to be a fast learner. Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed. Recognized for sustained scientific excellence. Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials. Has an expert-level of knowledge of the assigned or related disease area, as evidenced by ability to independently lead clinical development for highly complex products. Demonstrable ability to effectively apply business acumen to strategic scientific projects. Extensive knowledge of PK-PD, Pop-PK-PD analyses and techniques and the physiological/pharmacological aspects of drugs. Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees. When needed, ability to travel.
The salary range for this position is: $221,170.00 - $286,220.00. 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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* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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