Director, Clinical Research (MD) - Oncology (GU/GYN)

Director, Clinical Research (MD) - Oncology (GU/GYN) United States - California - Foster City, United States - New Jersey - Morris Plains Clinical Development & Clinical Operations Regular
Job Description
EXAMPLE RESPONSIBILITIES:

• Provides input into or leads the 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 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.

REQUIREMENTS:

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.

• MD or equivalent with 4+ years' clinical, scientific and/or drug development experience in the biopharma industry, healthcare, consulting, academia or a related environment.
• Board certification in Oncology is preferred, including familiarity with clinical solid tumor and/or hematologic medicine.
• Experience in the biopharma industry is preferred.
• 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.

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Job Requisition ID R0027885

Full Time/Part Time Full-Time

Job Level Director

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