Sr Associate Director/Director, Clinical Research

Employer
Gilead Sciences
Location
Belmont, CA
Closing date
Sep 26, 2021

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Sector
Other
Job Description
This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HBV cure. The SrAssociate Director/Director, Clinical Research position will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide, provide expertise in clinical medicine as a medical monitor, and contribute to cross-functional initiatives.

This is an opportunity to work in a dynamic role to support the clinical development of novel drugs for HBV cure. The SrAssociate Director/Director, Clinical Research position will play a key role at all stages of clinical development for product programs from the drug discovery stage through product registrations world-wide, provide expertise in clinical medicine as a medical monitor, and contribute to cross-functional initiatives.

Essential Duties and Job Functions:

Responsible for all scientific aspects of conceptualizing and planning trials.
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.
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.
Work with regulatory team in the preparation/review of regulatory documents, IND annual reports, IND safety reports, investigator brochures, and development plans.
Serves as a scientific and clinical resource within Gilead Clinical Research
Provides scientific and clinical guidance to Biology, Toxicology, Clinical Trials Management, Biometrics, Biomarkers, Global Drug Safety, Regulatory, and Project Management staff.
Assists in the clinical evaluation of business development opportunities.
Knowledge, Experience and Skills:

MD/DO,/PharmD/PhD with 3+ years of relevant industrial or academic experience in clinical / translational research with basic understanding of Good Clinical Practices. Level will commensurate with experience.
Experience in immunology, hepatology, and/or infectious disease is desirable but not required
Excellent organizational and interpersonal skills are critical
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, 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.
Foster City, CA based role

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