Clinical Development Director

1 week ago

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

Job Title: Director, Clinical Development Hepatitis

Job Summary:

The Director, Clinical Development Hepatitis provides clinical leadership and input on clinical studies, supporting the hepatitis programs. This role is responsible for leading or assisting on multiple components of clinical trial programs in Hepatitis clinical development.

Key Responsibilities:

  • Provides scientific and clinical guidance to cross-functional teams and colleagues to meet clinical development project deliverables and timelines.
  • Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports, and health authority inquiries.
  • Manages the clinical development component(s) in the preparation/review of regulatory documents, investigator brochures, and development plans.
  • Coordinates the collection and assimilation of ongoing data for internal analysis and review.
  • Coordinates and manages the preparation and/or review of data listings, summary tables, study results, and scientific presentations.
  • Presents scientific information at scientific conferences as well as clinical study investigator meetings.
  • Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.

Requirements:

  • Preference for MD/DO and 4+ years of clinical or biotech/pharma industry experience with a proven success record in clinical research studies, trial design, execution, and oversight.
  • PharmD or PhD in clinical research or clinical pharmacology with 8+ years' scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia, or a related environment.
  • Preference for applicants with experience in hepatitis D and/or B.
  • Relevant experience in Hepatology is preferred.
  • Experience in the biopharma industry is preferred.
  • Experience working on cross-functional project teams in a global development team.
  • Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications, and presentations is preferred.

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.
  • Proven analytical abilities as demonstrated through past experience and/or academic research.
  • Understands drug development phases and the nature of associated clinical trials across phases.
  • 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.
  • When needed, ability to travel.

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