Senior Director, Regulatory Affairs, Precision Medicine
Senior Director, Regulatory Affairs, Precision Medicine
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle
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
This position can sit out of the following sites: Foster City, CA, Morris Plains, NJ, Seattle, WA or Remote by exception only.
The Regulatory Affairs organization at Gilead has an exciting and highly impactful opportunity available for a Senior Director to help build and establish the Precision Medicine regulatory function at Gilead. The Regulatory Precision Medicine leader will report into the VP of Regulatory Affairs, Oncology, and will be accountable for the development, oversight and execution of global regulatory strategy to support biomarkers, companion diagnostics and other devices across therapeutic areas.
- Ensures development of global regulatory strategies that supports a precision medicine approach to integrates drug/diagnostic regulatory and submission plans and represents Gilead in key interactions with Health Authorities.
- Ensures high quality collaboration with global regulatory leads and provides guidance to the regional liaisons and collaborates in strategic meetings with health authorities.
- Provides strategic and technical input on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products.
- Ensures high quality collaboration with the Development Biomarker Sciences team to develop biomarker, companion diagnostic and other devices and is recognized as an expert resource for precision medicine regulatory advice across departments.
- Remains on the forefront of the relevant science, competitive landscape and policy including detailed competitive intelligence
- Understands current global and regional trends in precision medicine, including IVDD & IVDR, and takes a leadership role in assessing and communicating the impact of these requirements to the business.
- Ensures compliance of all programs with regulatory requirements for diagnostics and devices.
- Initiates or contributes to local and/or global process improvements which have a significant impact on business.
- Provides ongoing feedback and accountable for coaching, and career development to staff in order to maximize their potential.
Knowledge, Experience and Skills
- A science degree (Ph.D., M.D., PharmD, MS) or BS Significant experience in regulatory affairs and diagnostic related development (10+ years).
- Good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals in the US, EU and other regulatory jurisdictions.
- Understanding of strategic and tactical deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
- Understanding of policy, laws, regulations and guidelines globally as they apply to diagnostic development and approval.
- Good interpersonal skills to leverage strengths of the team and collaborate with peers in a cross-functional environment.
- Direct experience in developing strategy and leading teams through interactions with health authorities.
- Successful track record of leading through influence and working across complex, global organizational matrices.
- Preferably managed direct report(s)
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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 for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' poster.
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