Director, Medical Affairs Research Policy & Governance

职位描述

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

The Director of Medical Affairs (MA) Policy and Governance is responsible for developing, revising, and implementing the research procedural frameworks and cross-functional support for global and local MA research across all therapeutic areas as well as MA-funded externally sponsored research (ie independent Investigator Sponsored Research and collaborative research. The position will work collaboratively with other functions to ensure consistency and synergies in procedures and responsibilities related to all aspects of late phase research within MA and implement best practices across TAs; encourage collaboration between MA, Clinical Operations, Health Economics Development and HEOR. In addition, the incumbent will be responsible for training on MA-related research activities by the global and local functions as well as representing MA in compliance related issues.

Essential Duties and Job Functions:

• Lead development and revision of all MA Research procedures and policies ensuring the procedural framework is updated promptly to reflect changes in scope and responsibilities.
• Continuously evaluate and improve internal MA research processes to ensure efficiency and effectiveness in supporting MA-led Gilead sponsored and externally sponsored research.
• Lead a forum for Research Committee members to identify and minimizes unnecessary bureaucracy and optimize research-related workflows resulting in high quality proposals and standardization and improvements in proposal reviews
• Develop, deliver and update a comprehensive training program on MA research policies and procedures including other relevant functional policies and procedures where necessary to global and local research committee chairs, committee members and reviewers, MA study Leads, Global Project Managers, and Regional Representatives
• Operationalize MA-Research processes among MA internal stakeholders and cross functional partners, including ongoing training and educational sessions to enhance compliance in the execution of MA research
• Act as a trusted technical subject matter expert and key point of contact for all matters governed by Global and Local MA Research policies and procedures with a robust understanding other related policies and procedures within Development (eg CDS-RWE) for global, and regional teams across all therapeutic area.
• Primary MA contact for cross functional workstreams for compliance-related incidence and audits for MA research studies including deviations, CAPAs, as well as support for robust root cause and impact investigations and resolution.

Knowledge, Experience and Skills:

• BS/BA required. Advanced degree strongly preferred (e.g. MPH, PhD, PharmD in life sciences: biological, pharmaceutical sciences, epidemiology, or similar)
• Proven track record managing or contributing to the execution of interventional phase 3 and phase 4, industry sponsored research and/or observational research across the lifecycle. Experience in academic clinical research preferable
• Strong knowledge of GXP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards
• Minimum of 6-8 years of experience with broad exposure to business functions such as Ethics and Compliance, Legal, Quality
• Must have strong attention to detail, excellent written and verbal skills
• Aptitude to effectively influence, direct, and collaborate with internal and external team members at all levels without defined authority as well as the ability to work successfully in cross functional teams
• Demonstrated ability in driving quality process improvement initiatives
• Demonstrated ability to analyze complex issues, develop effective strategies, and make sound recommendations or decisions.
• The ability to multitask on a number of projects with tight timelines while maintaining excellent attention to detail is required
• Thorough knowledge and experience with Microsoft Office suite
• Ability to travel as dictated by business needs

The salary range for this position is: $243,100.00 - $314,600.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

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

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Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 ApplicantAccommodations@gilead.com for assistance.

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