Director, Clinical Development (MD)

Gilead Sciences • Foster City, CA

4d

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. The Director, Clinical Development provides clinical leadership and input on clinical studies, supporting the HIV programs. You will typically lead or assist on multiple components of clinical trial programs in HIV clinical development. You will help design, conduct, and evaluate Phase 1-4 clinical trials and provide expertise in clinical hepatitis. You will primarily be involved in developing drugs for HIV treatment and cure. Working in collaboration with the Clinical Leads and Global Development Team Leads, you will be responsible for various aspects of ongoing clinical trial program-related activities within the HIV therapeutic area. These activities include, but are not limited to, collaboration on functional area activities during program implementation, clinical study start up/execution/close out, specifically including, medical monitoring, data analysis/reporting and support of Regulatory filings, and clinical development input into regulatory documentation, publications, and scientific presentations.

Requirements

• 12+ Years with BS/BA OR 10+ Years with MS/MA or MBA
• Excellent scientific written and oral communication skills are required.
• Must possess a proven ability to work highly effectively with multiple departments.
• Must be capable of working with attention to detail in a time sensitive environment.

Nice To Haves

• 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.
• Relevant experience in HIV 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.
• 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.
• Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.

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 proto‐col design, clinical study reports and health authority inquiries.
• Provides ongoing clinical monitoring for clinical trials, including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• 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.
• Provides high level and complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory and Project Management staff to meet project deliverables and timelines.
• Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries.
• Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.
• Adheres to regulatory requirements of study conduct and industry standards of Good Clinical Practice as well as Gilead SOPs.
• Also manages the clinical research component in the preparation/review of regulatory documents, IND annual reports, IND safety reports, 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.
• Leads two or more specific components of cross-functional strategic initiatives.

Benefits

• 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, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
• Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees