Director, Global Regulatory Affairs, Precision Medicine

Director, Global Regulatory Affairs, Precision Medicine Director, Global Regulatory Affairs, Precision Medicine United Kingdom - Cambridge Regulatory Regular Job Description

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

As a Director, Global 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 Vice President, Global Regulatory Affairs Oncology and Precision Medicine, and collaborate with the biomarker team and global/regional regulatory liaisons to provide Precision Medicine global regulatory guidance. You will provide regulatory strategy and support, ensuring 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 through all stages of clinical development 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, lead, and communicate a business plan to and implements high quality and globally aligned precision medicine regulatory strategies to support Gilead assets from early development through registration and represent 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 compliance of diagnostics used in therapeutic trials with global and local regulatory requirements (such as 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.
• Support or lead training related to the IVD/CDx development & registration activities.
• Ensures compliance with established practices, policies, processes, and any regulatory or other requirements.
• Represent Gilead with trade organizations, with travel to key meetings on an annual basis.

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.

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, notably IVDR) 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, matrixed environment.
• When needed, ability to travel.

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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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

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

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