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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical pharmacologypharmacokinetic analysisstudy protocol designdata analysismodeling and simulationclinical study managementregulatory submissionsclinical documentationPK-PD analysisclinical project deliverables

Soft Skills

verbal communicationwritten communicationinterpersonal skillsproblem-solvingflexibilityadaptabilityleadershipteam managementstrategic thinkingbusiness acumen