Sr. Director, Clinical Development (MD) Oncology
United States - New Jersey - Morris Plains
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.
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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 Development (MD) Oncology
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 therapeutic area.
- The Clinical Research MD will report to a more senior member of the Oncology clinical team, who has direct responsibility for the overall research strategy and clinical and scientific development activities.
- Strategic Thinking: Understands the competitive landscape within Oncology, including having a perspective on how clinical practice and patient needs are evolving as well as therapeutic area trends and their relevance to the Gilead portfolio; Responsible for clinical development's assessment of both internal and external opportunities to advance Gilead's portfolio and actively seeks opportunities to form external partnerships to strengthen Gilead's Oncology portfolio and probability of success.
- Influence and Partnership: Establishes and maintains strong, collaborative relationships with Research, Development, Business Development, and Commercial stakeholders; Establishes and maintains an external network including relationships with the innovation community, medical and scientific organizations, governmental bodies and patient organizations within Oncology; Leverages to identify opportunities and sources of innovation; Sets the expectation for and models a collaborative and enterprise mindset.
- Delivery Excellence: Responsible for ensuring that key Oncology program is aligned with disease area strategies and appropriate activities are prioritized; Facilitates efforts across therapeutic area and is accountable for the technical execution of programs within the Oncology portfolio; Supports the operational direction for programs clinical research teams within the Oncology organization, which includes responsibility for scientific and medical aspects of clinical studies such as protocol design, risk benefit assessment, and medical monitoring.
- Innovation: Thinks creatively and brings innovative solutions to the TA; Identifies and leverages advances in clinical development, where appropriate, such as real-world data, analytics, and innovative trial designs.
- Decision-making: Supports a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makers.
Essential Duties and Job Functions:
- Communication: Advocates on behalf of Gilead and effectively communicates complex medical/clinical concepts in both written and oral communication to both internal and external stakeholders
You have a track record of successfully developing Oncology therapies. You will have the ability to thrive in a matrix environment and work collaboratively with internal stakeholders across different functions. You have practical experience in identifying, vetting and managing external partnerships including vendors, academic and industry collaborators. You have excellent oral and written communication skills, including the ability to translate between business leaders, scientists, and medical professionals.
*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 or oversees medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management, and drug safety surveillance.
- 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 degree and board certification or equivalent years of clinical research experience in Oncology
- Two (2) + years required in the pharmaceutical industry with a proven success record in clinical research studies and trial design.
- *Executive Medical Director Level to be considered with 6+ years of drug development experience either within biopharma industry, academic/research organizations early through late stage development, including the design and conduct of clinical studies
- Relevant industrial or academic experience in clinical research with basic understanding of Good Clinical Practices.
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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 firstname.lastname@example.org
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