Sr Director, Medical Affairs

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
 

This position is a member of the Medical Affairs Research (MAR) Leadership Team and will report to the VP, Head of MAR.

Key Responsibilities:

• Ensures operational oversight of Investigator Sponsored Research (ISR) and Collaborative studies including but not limited to Fair Market Value and feasibility assessment, contract negotiation support, tracking and publication follow-up
• Ensures operational oversight of Managed Access Programs (MAP), including but not limited to Compassionate Use Program (CUP) and Expanded Access Program (EAP)
• Develops and implements a strategic plan to drive continuous improvements in the operational aspects of the studies under the purview of the team, including interactions with CROs
• Primary liaison to the Development Clinical Operations group to make sure processes, policies and talent management approaches are optimally aligned
• Leads and manages a team of direct reports and may manage other people leaders. Hires, develops and retains diverse top talent in the team. Sets goals for the team and individual direct reports. Coaches direct reports on their performance, development and career interests
• Collaboration with colleagues in Clinical Operations, Medical Affairs, Real World Evidence, Health Economics and Outcomes Research, Project Management, Regulatory, Biometrics, Clinical Research and Affiliates globally ensuring delivery of assigned studies
• Leads development of all resource plans for all assigned programs across multiple therapy areas to ensure optimal deployment and allocation of internal and external resources (ARO/CRO/FSP)
• Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team
• Ability to initiate and lead departmental or interdepartmental strategic initiatives
• Proven ability to effectively communicate scientific, medical, and organizational concepts to internal and external customers
• Contributes leadership input into all study-related documentation, including study protocols
• May lead development of standard operating procedures (SOPs) and other procedures or documentation within Medical Affairs and/or cross-functionally
• Initiates continuous efforts in reviewing and identifying best practices among study teams and enforcing standardization among teams
• Plays a lead role in representing Medical Affairs Clinical Operations within cross-functional organizational initiatives to drive ongoing efficiencies and operational excellence

Basic Qualifications:

• 14+ Years with BS/BA
  OR
• 12+ Years with MS/MA or MBA
   

Preferred Qualifications:

• Expert knowledge of the biopharma industry, including in-depth understanding of other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans and objectives
• Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools
• Thorough understanding of global pharmaceutical regulatory requirements and impact on development and execution of clinical trials
• Strong financial acumen necessary for the management of clinical trial budgets
• Exceptional interpersonal skills and understanding of team dynamics
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