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Sr. Director, Clinical Research- Oncology/Hematology

Employer
Gilead Sciences
Location
Belmont, CA
Closing date
Aug 2, 2021

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Job Description
Sr. Director, Clinical Research (MD) - Oncology/Hematology

Gilead has declared Hematology-Oncology as one of the key therapeutic areas for future growth. Gilead is growing its pipeline in immune-oncology through internal research, partnerships and acquisitions. This role provides an exciting opportunity to participate in the future growth of Gilead Oncology. This role will play a key role in development of pipeline programs.

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 successful candidate will have oversight for ongoing and planned product trials within the Oncology Disease therapeutic area including a focus on CD47/SIRPa therapeutics from the recent acquisition of Forty-Seven, Inc.

The Clinical Research MD will report to the Senior Director of Clinical Research, Oncology who has direct responsibility for the research strategy and clinical and scientific development activities.

Primary responsibilities include providing ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance.

Responsible for developing clinical trial design and protocols and providing input to clinical study reports as well as Health Authority inquiries.

Leads two or more specific components of cross-functional strategic initiatives.

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.

Critically analyzes clinical and translational data and help to formulate clinical strategies

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 or equivalent; MD, PhD preferred

Zero (0) to three (3) years' experience with a proven successful record in clinical research studies and trial design is required.

Highly preferred to have experience in Oncology Disease drug development.

Disease area expertise in Hematology with minimal industry experience will also be viewed favorably.

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.

Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.

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).

Strong familiarity with good clinical practices and International Conference on Harmonization Guidelines is preferred.

Must be capable of working with attention to detail in a time sensitive environment

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