Director, Medical Governance, R&D Quality and Medical Governance
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 #CreatingPossibleFor Current Gilead Employees and Contractors:
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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.
Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?
Research & Development (R&D) Quality and Medical Governance is seeking a Director of Medical Governance to play a pivotal role in creating, reinforcing, and sustaining a strong culture of quality, compliance, governance, and risk management for our cross-therapeutic area medical affairs activities, including but not limited to: medical affairs strategic and tactical planning, governance and controls on HCP relationships and arrangements, scientific materials and market research, medical affairs governance and compliance metrics, self-inspections, compliance education, training and communication, and more.
The Director of Medical Governance will lead the implementation of process controls for Medical Affairs to provide assurance of adherence to guardrails and promote culture of collaboration with accountability. This role will partner closely with Medical Affairs, Legal, Commercial and other R&D functions in applying a risk-based approach to key activities, which include strategic planning, scientific materials, and external engagements. This role will also leverage document management and learning solutions that are managed by R&D Quality Process, Documentation and Learning to advance a culture of quality and compliance across Gilead.Primary ResponsibilitiesMedical Governance and Compliance Ecosystem Structure
Medical Governance and Compliance Consultation
- Partner with the Executive Director of Medical Governance, Medical Affairs leaders and teams, and other internal partners and stakeholders in evaluating and updating medical affairs strategic and tactical planning processes and tools to ensure alignment with governing regulations and standards and Gilead policies and procedures for medical affairs compliance
- Partner with the Executive Director of Medical Governance, Medical Affairs leaders and teams, and other internal partners to evaluate, recommend, and design an overarching structure for Medical Affairs compliance that addresses the ecosystem of medical affairs activities both internally and externally, including but not limited to recurring and hoc governance forums, compliance education and training, compliance metrics, documentation management and reporting, HCP engagement and relationship management, scientific materials, market research, self-inspections and more
- Proactively identify areas where policies and procedures may be unclear and collaborate with team stakeholders to establish practical resolutions
- Maintain a comprehensive Medical Governance program which includes policy and guidance support, compliance-focused education, and oversight of key processes
Medical Governance and Compliance Culture
- Serve as an expert to provide guidance on and interpretation of compliance regulations, standards, and management systems for all relevant medical affairs activities
- Interface with other Regulatory, Safety and Quality colleagues, other R&D functions, Legal, Commercial, and other business functions at both global and affiliate levels
- Proactively identify quality and compliance risks. Maintain a risk inventory of the Medical Affairs landscape, providing risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address compliance risks
- Collaborate with Medical Affairs Quality Business Partners
- Develop trusted relationships with Medical Affairs associates at all levels to promote an accountable complaint culture
- Conduct self-inspections in coordination with internal auditing and other business partners
- Develop and deliver training for to ensure standards are well understood and followed by all colleagues and relevant external partners
- Assure completeness and currency of documentation that describe policy and process practices across Medical Affairs non-GxP activities
- Support management of internal audit and regulatory inspection activities such as readiness preparation, inspection management, and/or response management as needed
- Assist with the resolution of relevant audit and monitoring findings and the implementation of corrective actions
- Drive change management initiatives and promote a culture of quality, compliance and patient centricity
About Gilead R&D Quality and Medical Governance
- MA/MS/MBA/PharmD/PhD with 12+ years' relevant experience.
- BA/BS with 14+ years' relevant experience.
- Relevant experience in quality and compliance governance and risk management in the biopharmaceutical or related industry
- Experience defining and leading quality and compliance governance for GxP or non-GxP practices and associated continuous improvement projects is preferred
- Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs, standards, metrics, and practices that drive quality and compliance across cross-functional operations and activities
- Familiarity with post-marketing medical affairs operations and activities
- Deep understanding of the PhRMA code regulations, standards, and business requirements
- Effective communication and interpersonal skills, to include developing executive stakeholder relationships and delivering impactful presentations and other communications across organizational levels
- Excellent organizational and project management skills
- Previous people management experience and a track record of effective leadership, whether through direct line or matrix team management
Gilead R&D Quality and Medical Governance is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team.
We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.
We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career.
Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?
The salary range for this position is: $199,835.00 - $258,610.00. 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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