Director, Medical Affairs Research Policy & Governance

Gilead; Uxbridge; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Director of Medical Affairs Research Policy & Governance to lead the development and implementation of research frameworks. The role involves collaborating with cross-functional teams to enhance research processes and ensure compliance with regulatory standards. This position offers the chance to make a significant impact in the healthcare sector, driving innovative solutions to improve patient outcomes. Join a dynamic team dedicated to tackling some of the world's most pressing health challenges and be part of a mission that truly makes a difference.

Qualifications

• Proven track record in managing interventional phase research.
• Strong knowledge of regulatory compliance and industry standards.

Responsibilities

• Lead development of MA research procedures and policies.
• Evaluate and improve MA research processes for efficiency.
• Develop training programs on MA research policies.

Skills

Interventional Phase 3 and 4 Research

Regulatory Compliance (GXP/ICH/FDA/EU)

Process Improvement Initiatives

Microsoft Office Suite

Attention to Detail

Verbal and Written Communication

Cross-Functional Collaboration

Education

BS/BA in Life Sciences

Advanced Degree (MPH, PhD, PharmD)

Tools

Microsoft Office Suite

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

Director, Medical Affairs Research Policy & Governance

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
• 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

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.