Senior Director, Clinical Research (MD) – Oncology, Foster City, CA
United States – California – Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Senior Director, Clinical Research (MD) – Oncology
Gilead has declared Hematology-Oncology as one of the key therapeutic areas for future growth. After having made a significant investment in cell therapy (with acquisitions of Kite, Cell Design Labs), Gilead is now poised to grow its pipeline in immune-oncology and targeted therapies.
This role provides an exciting opportunity to participate in the future growth of Gilead Oncology.
This role will be the Project Team Leader of a key molecule in development, and will focus on supporting ongoing programs as well as evaluation of internal and external opportunities for expanding the pipeline.
* The successful candidate will have oversight for ongoing and planned product trials within the oncology therapeutic area.
* The clinical research physician will play a key role at all stages of development for product programs from the drug discovery stage through product registrations world-wide.
* The Clinical Research MD will report to a more senior member of the oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
* Will be part of a team responsible for all scientific aspects of conceptualizing and planning trials.
* Will be part of a team responsible for the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
Essential Duties and Job Functions:
* Provides ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
* Ensures adherence to regulatory requirements of study conduct and industry standards of Good Clinical Practice.
* Coordinates the collection and analysis of clinical data for internal analysis and review.
* Will be part of a team responsible for managing the preparation and/or review of data listings, summary tables, study results, study reports, and clinical NDA sections.
* Prepares presentations for scientific conferences as well as for clinical study investigator meetings and expert advisory meetings.
* Develops manuscripts for publication in peer-reviewed journals.
* Will be part of a team responsible for defending the clinical development program before regulatory authorities.
* Serves as a scientific and clinical resource within Gilead Clinical Research
* Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Global Drug Safety, Regulatory, and Project Management staff.
* Assists in the clinical evaluation of business development opportunities.
Knowledge, Experience and Skills:
* MD (Board Eligible Preferred)
* Three (3)+ years’ experience required in pharmaceutical industry with a proven success record in clinical research studies and trial design.
* Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.
* Experience in oncology drug development.
* Ability to think analytically and strategically to formulate, develop, and execute clinical plans.
* Strong leadership skills with an ability to set vision, lead change, and mentor others.
* Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
* Excellent scientific written and oral communication skills.
* Facility with engaging internal and external experts in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results.
* Well-developed sense of integrity, strong work ethic, scrupulous attention to detail, clear ability to establish and maintain timelines, and persistent commitment to ensuring a high level of quality.
* Ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings (~20-30% travel expected).
If this is not the right move for you now but remain interested in a career at
Gilead Sciences please connect with us via our talent community:
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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