For Current Gilead Employees and Contractors:

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Job Description

Making an impact on a global scale

For over 30 years, Gilead has been a leading innovator in the field of virology, having developed many of today’s leading medicines for treating and preventing HIV and viral hepatitis. More recently, Gilead has expanded its oncology portfolio, and seeks to become a leader in this critical disease area.

In this role as Director, Clinical Development, you will lead regional components of clinical trial programs in Oncology clinical development. For the assigned projects, you are accountable for various aspects of regional ongoing clinical trial program-related activities. These activities include, but are not limited to, study protocol preparation, additional study or investigator documentation, contributions to data analysis plans, study reporting, and clinical development inputs into regulatory documentation, publications and scientific presentations.

Reporting to the SVP, Clinical Development Oncology, this role is based at our European Headquarters in Stockley Park, UK.

Key Responsibilities:

Provides input into or leads the regional development of the Target Product Profile and Clinical Development Plan for assigned molecules /products.

• Provides scientific and clinical guidance to cross-functional teams and colleagues to meet regional clinical development project deliverables and timelines.
• Provides input into, or otherwise leads, clinical trial protocol design, clinical study reports and health authority inquiries.
• Provides ongoing medical 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.

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Essential - PharmD, PhD or MSC degree in clinical research or clinical pharmacology with significant scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment is required.
• Highly desirable - MD with board certification in Oncology, including familiarity with clinical oncology medicine.
• Significant experience working on, with and leading cross-functional project/program teams in life sciences, healthcare, consulting or academia.
• Experience taking the lead on study concept and protocol design, regulatory filings, clinical publications and presentations.
• Demonstrated excellence in complex project management and effectively managing multiple clinical project deliverables and priorities through matrix management and leadership.

Knowledge & Other Requirements

• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Has core expertise in the assigned or related disease area, as evidenced by ability to independently lead clinical development for deliverables for one or more projects.  
• Has thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
• Strong communication and organizational skills. Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
• When needed, ability to travel.

Gilead Core Values

• Integrity (Doing What’s Right)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)
• Inclusion (Encouraging Diversity)

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.