Associate Director, Regulatory Affairs, Precision Medicine

Associate Director, Regulatory Affairs, Precision Medicine
United States - California - Foster CityUnited 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. Gilead’s 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 company’s five core values. That’s 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

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
Job Description


As an Associate Director Regulatory Affairs, Precision Medicine you will develop and execute Precision Medicine regulatory strategies in alignment with the drug global regulatory strategy in collaboration with cross functional stakeholders across the Gilead therapeutic areas and in compliance with the appropriate regulations. You will need to work closely with the Senior Director Regulatory Affairs, Precision Medicine and global/regional regulatory liaisons to provide Precision Medicine regulatory guidance and support to ensure communication of a clear vision for the translational discovery, development and validation of biomarkers in clinical studies. You will provide operational and technical regulatory assistance from Proof-of-Concept through global registration for IVD projects. In addition, you may be involved in the identification of predictive biomarkers that may influence drug product's clinical development strategy and proof of mechanism.

EXAMPLE RESPONSIBILITIES:

• Represents Regulatory Affairs precision medicine subject matter expertise on cross-functional/cross-regional Regulatory Teams and other Sub-teams involved with the development and validation of IVDs (e.g., Study Management, Clinical, Biomarkers) and presents to senior leadership as required.
  
• Develops and implements high quality and globally aligned precision medicine regulatory strategies to support Gilead assets from early development through registration and represents Gilead in key interactions with Health Authorities.
  
• Maintains current understanding of global IVD/CDx regulations, assesses and communicates their impact on drug and IVD/CDx development & registration activities, respectively.
  
• Provides IVD regulatory input during clinical development to ensure diagnostics used in therapeutic trials is in compliance with global and local regulatory requirements (including US FDA and EU IVDR).
  
• Provides regulatory strategy relative to premarket submission, IVD partnering, FDA and other Health Authority interface, regulatory policy, and practice.
  
• Leads the preparation and filing of HA briefing books, including coordination and planning for pre-Submission meetings with FDA and IDEs. Provide inputs on key development documents, clinical protocols, study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs, device clinical performance study applications and labeling for drug and diagnostic products.
  
• Manage internal and external stakeholders to advance scientific and technical capabilities to design and execute translational research and precision medicine across all therapeutic areas.
  
• Contributes to local and/or global process improvements which have a significant impact on business.
  
• Ensures compliance with established practices, policies and processes, and any regulatory or other requirements.
  
• Deputizes for the Senior Director Precision Medicine as required
  

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

U.S. Education & Experience

• PharmD/PhD with some relevant experience.
  
• MA/MS/MBA with 8+ years' relevant experience.
  
• BA/BS with 10+ years' relevant experience.
  
• Significant regulatory, quality, compliance or related experience supporting medicinal products with experience in vitro diagnostic development strongly preferred.
  
• Understanding of global policy, laws, regulations and guidelines as they apply to diagnostic development and approval strongly preferred
  
• Understanding of molecular technologies and the impact on outcomes and diagnostic results
  
• Experience successfully leading departmental and cross-functional teams without authority.
  
• Experience authoring and implementing processes.
  
• Experience working with one or more Gilead therapeutic areas and varying stages of drug development is strongly preferred.
  

Rest of World Education & Experience

BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience in in vitro diagnostic development strongly preferred

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
  
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
  
• Demonstrates advanced knowledge of regulatory requirements (including those related to IVDs) and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives.
  
• In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
  
• Able to represent Gilead to regulatory authorities when managing standard or more routine negotiations.
  
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
  
• Ability to lead and influence programs, projects and/or initiatives.
  
• Strong interpersonal and communication skills with ability to rapidly understand and navigate team dynamics.
  
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.
  
• When needed, ability to travel.
  

For jobs in the United States:

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 careers@gilead.com for assistance.

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Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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