Director, Clinical Research (MD) - Oncology/Hematology
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)