Director, Clinical Research (MD) - Oncology/Hematology

Location
Foster City, California
Salary
We offer a competitive salary and benefits package.
Posted
May 27, 2021
Closes
Jun 26, 2021
Position
Director
Education
MD, MD / PHD, PHD
Hours
Full Time

We want the courageous, the self-starters, the compassionate doers, the make-it-possible-ers. Because those are the kind of people who are best able to make an impact for people with cancer. So, what’s missing? Just someone like you.

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

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 and will support evaluation of internal and external opportunities for expanding the pipeline.

  • 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 Trodelvy from the recent acquisition of Immunomedics.
  • The Clinical Research MD will report to the VP of Clinical Research, Oncology who has direct responsibility for the overall research strategy and clinical and scientific development activities.
  • Primary responsibilities include providing high level input to complex Phase I-IV clinical trial protocol design and clinical study reports as well as Health Authority inquiries. 
  • Provides ongoing clinical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance. 
  • 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.
  • 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

 

We offer a competitive salary and benefits package.  Apply today at Director, Clinical Research (MD) - Oncology/Hematology - Foster City, CA (myworkdayjobs.com)

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