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Director, Clinical Research

Employer
Gilead Sciences
Location
Belmont, CA
Closing date
Oct 22, 2021

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Sector
Other
Organization Type
Corporate
Job Description
Specific Responsibilities:

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HIV treatment. This Director, Clinical Research position will design, conduct, and evaluate Phase 1, 2, and 3 clinical trials for novel drugs for HIV treatment and provide expertise in clinical HIV medicine as a medical monitor. You will have an opportunity to contribute to developing drugs to treat, prevent, and possibly even cure HIV infection.

The clinical research physician will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide.
The successful candidate will have oversight for ongoing and planned product trials within the HIV therapeutic area.
The Clinical Research MD will report to a senior member of the HIV clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
Essential Duties and Job Functions:

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.
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 with Board Certification in Internal Medicine/Infectious Diseases preferred
Successful leadership and management experience
Excellent organizational and interpersonal skills are critical
Passion for and experience with HIV medicine preferred
Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.
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.
Ability to partner, influence and inspire others.
Experienced 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% travel expected).

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