Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted
virtually and some roles will be asked to temporarily work from home. Over the coming weeks and
months, we will be implementing a phased approach to bringing employees back to site to ensure
the health and safety of our teams.
Please log onto your Internal Career Site to apply for this job.Job Description
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 Director, 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
- 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.
- Be the face of the study for investigators and serve as primary contact for site medical queries
- Leads two or more specific components of cross-functional strategic initiatives.
Essential Duties and Job Functions:
- Will be part of a matrix 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 to 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:
- GMC Registered Medical Doctor
- Previous 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 Harmonisation Guidelines is preferred.
- Must be capable of working with attention to detail in a time sensitive environment
Gilead Core Values
- Integrity (always doing the right thing)
- Teamwork (collaborating in good faith)
- Excellence (working at a high level of commitment and capability)
- Accountability (taking personal responsibility)
- Inclusion (encouraging diversity)
Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.