Assoc Clinical Pharmacology Director

Role Summary

Associate Director, Clinical Pharmacology, based in Foster City, CA or Parsippany, NJ. The role involves leading design and execution of clinical pharmacology studies, developing pharmacology plans, and providing cross-functional input to product development and regulatory filings within a drug development team.

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 clinical pharmacology studies of increasing complexity, including 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.

Qualifications

• Required: Doctorate and 5+ years of relevant experience OR
• Required: Master’s and 8+ years of relevant experience OR
• Required: Bachelor’s and 10+ years of relevant experience
• Preferred: PhD or PharmD in pharmaceutical sciences, pharmacology or related discipline

Skills

• Excellent verbal, written, and interpersonal communication skills; ability to convey complex technical information clearly to others.
• Experience using pharmacokinetic software (e.g., WinNonlin).
• Experience leading small cross-functional project teams and managing clinical project deliverables through matrix management.
• Extensive experience leading clinical pharmacology study concept and protocol design, authoring development plans.
• Experience contributing to regulatory filings; supporting clinical publications and presentations.
• Fast learner; able to adapt to change and move between projects; provide support/expertise where needed.
• Thorough knowledge of FDA and EMA regulations, ICH guidelines, and GCP governing clinical studies; strong knowledge of regulatory requirements related to clinical pharmacology.
• Ability to apply business acumen to strategic scientific projects; travel as needed.

Education

• Doctorate with 5+ years of relevant experience, or Master’s with 8+ years of relevant experience, or Bachelor’s with 10+ years of relevant experience.