Associate Clinical Pharmacology Director

Job Description

At Gilead we are searching for an Associate Director, Clinical Pharmacology based in Foster City, CA or Parsippany, NJ supporting drug development in Virology and Pediatrics therapeutic areas.

• Provide input into product development strategies and research or clinical development plans for assigned products or projects.
• Author the clinical pharmacology plan for one or more products in the assigned disease or therapeutic area.
• Lead and manage the design and conduct of clinical pharmacology studies of increasing complexity, including leading the cross‑functional study team.
• Design clinical pharmacology study protocols, data analysis, modeling and simulation plans.
• Lead study protocol review discussions concerning scientific and procedural aspects of pharmacology study design.
• Work with cross‑functional partners and study sites to implement and monitor studies and address clinical issues arising from studies.
• Direct activities and resources for both internal and external study partners.
• Manage study timelines and resources to ensure timely and accurate execution of studies.
• Conduct PK‑PD and related analyses and provide clinical pharmacology input into study documentation, data analysis/management plans and scientific presentations or literature.
• Analyze, interpret and author documents for clinical and regulatory submissions.
• Present project updates and other key milestone information to cross‑functional partners and stakeholders.
• Support business development or due diligence activities as a clinical pharmacology expert.
• Represent clinical pharmacology for the assigned project team in interactions with regulatory agencies.
• Anticipate problems that may arise in clinical trials and develop solutions for these using precedents and original thinking.
• Adhere to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Bachelor’s Degree and Ten Years’ Experience OR Master’s Degree and Eight Years’ Experience OR PhD/PharmD and Five Years’ Experience

• 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.
• Experience using pharmacokinetic programs 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.
• Experience supporting clinical publications and presentations.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change; able 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.
• Demonstrated ability to effectively apply business acumen to strategic scientific projects.
• Willingness to travel as needed.

• Create inclusion – model diversity and embed the value of diversity into team management.
• Develop talent – understand skills, experience, aspirations and potential of employees and coach them on performance and future growth.
• Empower teams – align goals, purpose, and organizational objectives, hold them accountable, and remove barriers.

The salary range for this position is:

• Bay Area: $ - $.
• Other US Locations: $ - $.

Benefits include company‑sponsored medical, dental, vision, and life insurance plans. Additional benefits and compensation information are available on our benefits page.

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or other non‑job related characteristics or other prohibited grounds specified in applicable laws.

Applicants who require accommodation in the job application process may contact Appli for assistance. Gilead Sciences will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Gilead provides a work environment free of harassment and prohibited conduct.