Sr. Director, Clinical Research (MD) - Oncology/Hematology Foster City, CA OR Seattle, WA Location
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
['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.
Essential Duties and Job Functions:
- 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.
Knowledge, Experience and Skills:
- 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.
- 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
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, Oncology diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com
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