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Clinical Development Director

2 months ago

Foster City, California, United States Gilead Sciences, Inc. Full time
Job Summary

We are seeking a highly skilled Clinical Development Director to join our team at Gilead Sciences, Inc. This is a critical role that will lead multiple components of clinical trial programs in IBD/inflammation clinical development.

Key Responsibilities
  • Lead the development of the Target Product Profile and Clinical Development Plan for assigned molecules/products.
  • Provide scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
  • Design, implement, and manage clinical trials, including protocol development, data analysis, and reporting.
  • Collaborate with regulatory agencies to ensure compliance with FDA and EMA regulations, ICH guidelines, and GCP.
  • Develop and maintain relationships with key stakeholders, including investigators, sponsors, and partners.
  • Manage and analyze data to inform clinical development decisions and optimize trial design.
  • Present scientific information at scientific conferences and clinical study investigator meetings.
  • Stay up-to-date with industry trends, regulatory requirements, and emerging technologies.
Requirements
  • MD or equivalent with 2+ years' clinical, scientific, and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
  • Board certification in gastroenterology is preferred, including familiarity with IBD management; alternatively, autoimmune disease training (e.g. Rheumatology, Allergy/Immunology, or Dermatology).
  • Experience leading small cross-functional project teams in clinical research or development.
  • Proven effectiveness managing clinical project deliverables through matrix management.
  • Ability to relocate to Foster City campus or West coast based.
Preferred Qualifications
  • 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.
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Knowledge of FDA and EMA regulations, ICH guidelines, GCP, and familiarity with standard clinical procedures.
  • Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
  • Strong communication and organizational skills.
What We Offer

Gilead Sciences, Inc. offers a competitive salary range for this position, as well as a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

We are an equal opportunity employer and are committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 federal, state and local laws.