Exec Director, Medical Affairs

At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

RESPONSIBILITIES (include but are not limited to):
Provide global Medical Affairs leadership for post-authorization research methodology across therapeutic areas and portfolios.

Ensure that the respective GMA and Development TA Heads and other members of senior management embrace the implementation of state-of-the-art research methodologies for post-authorization (Phase 4) medical affairs research.

Justify the rationale for proposed study methodology in cross-functional steering and /or governance committees.

In close collaboration with the MAR Head and the MAR Therapeutic Leaders drive the development of asset appropriate lifecycle research strategy (eg market archetype context) to be implemented in the respective Integrated Evidence Plans (IEP). Such strategies should be applicable to a range of assets in the portfolio.

Serve as a senior Medical Affairs representative in cross-functional governance and steering committees.

Partner with Clinical Development Regulatory Affairs Patient Safety HEOR and Commercial colleagues.

Oversee Medical Affairsled research activities including protocol strategy medical monitoring and dissemination of results.

Leads or otherwise oversees and directs clinical trial protocol design and clinical study reporting for an assigned asset.

Ensure compliance with global regulatory requirements patient safety standards GCP and Gilead policies.

Establish and maintain external scientific and thought-leader relationships.

Consult with Development colleagues who request assistance in implementing such novel approaches in earlier stage clinical trials (eg decentralized clinical trials).

Provides consultation to study teams for communications both written and oral with health authorities relative to study methodology or conduct.

Represent Gilead Medical Affairs through scientific presentations and publications.

Contribute Medical Affairs expertise to business development and strategic collaborations.

Build lead and develop high-performing Medical Affairs research teams.

May assist in the clinical evaluation of business development opportunities.

QUALIFICATIONS & EXPERIENCE:
MD from an accredited university is required with extensive Global Medical Affairs leadership experience preferably in a similar role in either pharma or large global biotech companies.

Clinical practice and/or biopharma industry experience in one or more of the following therapeutic areas is highly preferred: virology oncology inflammation and/or hepatology.

Demonstrated experience leading highcomplexity crossfunctional lifecycle strategies including short and longrange strategic planning governance and execution.

Prior peoplemanagement experience including direct reports is preferred.

Proven experience engaging with and presenting to senior executives with accountability for managing significant budgets and organizational resources.

Established track record of delivering largescale complex strategies and achieving sustained impact in dynamic environments.

Expertlevel understanding of drug development and postauthorization (Phase 4) research demonstrated through leadership of lifecycle evidence strategies and plans.

Recognized credibility in innovative study methodologies including large simple trials decentralized clinical trials ambispective designs and the application of digital technologies (e.g. patientgenerated data).

Strong working knowledge of global pharmaceutical regulatory requirements safety reporting obligations and their impact on clinical research design and execution.

Exceptional communication and organizational skills with the ability to translate complex scientific concepts into clear strategic recommendations and executable roadmaps. Demonstrated ability to influence align and mobilize senior leaders around crossfunctional strategies and objectives.

Ability to travel when needed.

Available for hire.

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Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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