Sr. Director, Medical Affairs, Gilead Oncology USMA, Trodelvy

Location
Foster City, CA
Posted
Dec 08, 2021
Ref
2688274
Required Education
Doctorate/PHD/MD
Position Type
Full time
Sr. Director, Medical Affairs, Gilead Oncology USMA, Trodelvy
United States - California - Foster City

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 #CreatingPossible


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. Headquartered in Foster City, California, Gilead has operations in North America, Europe, Asia and Australia. For more information please visit Gilead.com.

We have an exciting opportunity within US Medical Affairs for a Senior Director, Medical Affairs, Oncology. This role will be located in Foster City, CA.

Senior Director, Medical Affairs, Gilead Oncology USMA, Trodelvy

Reporting to the Executive Director US Medical Affairs (USMA), the Senior (Sr.) Director Medical Affairs strategic role is a leadership position responsible for developing and driving the US Medical Affairs Plan in support of Trodelvy®.

The key functions of this role will be to represent and consider the healthcare environment of the US with internal and external stakeholders involved in cancer therapies per Trodelvy indications, including the Global Medical Affairs team, US Patient Access and Quality team, Scientific Communications/Publications, Medical Affairs Outcomes Research, Commercial Strategy, Marketing, Value and Market Access, Clinical Research, US Public Affairs, US Government Affairs, Patient Engagement, Business Conduct (Legal), and the field-based US Medical Scientists.

Job Responsibilities

As an integral part of the Trodelvy cross-functional team, and in close collaboration with the Medical Director for Trodelvy in the U.S., Global Medical Affairs, Medical Patient Access and Quality, and cross-functional partners, the Sr. Director Medical Affairs will establish and maintain the tenor of Gilead's scientific communications with the HCP, Research, and Patient and related Communities in the US. The Sr. Director Medical Affairs will also provide frequent internal and external input into the development of both the US and Global Medical Affairs Strategic Plans for Trodelvy and will be accountable for the US medical POA.

Specific responsibilities for this role will include, but are not limited to:
  • Demonstrate deep subject matter expertise in Trodelvy clinical trials and its clinical use, as well as competitive products
  • Contribute to the development of the Global Integrated Strategic Plan (ISP) by providing US-based strategic perspectives
  • Develop strategies and implementation plans to define and address education, research and medical affairs insights and data generation needs within the US
  • Prepare presentation materials and present scientific data at internal meetings and external advisory boards
  • Serve on the Independent Medical Education (IMED) Committee to review and provide the US medical perspective on IMED proposals impacting the US
  • Support US medical efforts in global and regional Congress strategic planning and tactical execution
  • Provide medical and scientific leadership and support at key scientific meetings with US HCPs / patient presence
  • Serve as an information resource and trainer to Gilead colleagues, including the US Medical Scientists, including medical educational activities, grants and investigator-sponsored/collaborative studies.
  • Collaborate with Investigator Sponsored Research (ISR) Medical Affairs Sub Team (MAST) and Clinical R&D
  • Lead the delivery of timely, accurate and succinct communication of fair-balanced clinical and scientific presentations to healthcare professionals, both proactively and in response to requests for information, consistent with promotional compliance and regulatory requirements
  • Participate in the editorial review of all scientific content to ensure strategic alignment and accuracy
  • Support development of Trodelvy Publication Strategy
  • Support data generation activities through:
    • Critical review of global ISR, Ph 3b and Ph4 study proposals generated in the US
    • Review abstracts and/or manuscripts that result from US ISR grants
    • Communicate Gilead's commitment to scientific excellence through research and education
  • Provide strategic input to Global Medical Affairs Plan
  • Serve on Independent Medical Education (IMED) Committee to review and provide US medical perspective on IMED proposals with content intended for US audiences.
  • Oversee medical and scientific review of US promotional materials for PRC.
  • Coach and effectively manage an inclusive culture for the assigned US Medical Affairs team members via active observation of the team; establishment of clearly defined team and individual goals and objectives (quantitative and qualitative); implementation of processes to routinely monitor progress; recruit, motivate, retain and develop high performers.
  • Collaborate effectively and in a compliant manner with colleagues in other functional areas throughout Gilead.
  • Other activities, as assigned, to support US Medical Affairs strategy development and tactical execution


Requirements:
  • Advanced medical/scientific degree (i.e. PhD, MD, Pharm D)
  • Industry experience in Medical Affairs or success in a similar role outside of the biotech/pharmaceutical industry preferred.
  • 10+ years' similar experience in industry or related setting
  • Experience specific to oncology is preferred
  • Demonstrated ability to think strategically and translate that strategy into an actionable work plan.
  • Excellent written, verbal and interpersonal, relationship-building, negotiating and communication skills.
  • Excellent organizational skills to support project planning across multiple activities, and to anticipate and prioritize workload.
  • Excellent teamwork skills.
  • Attention to detail and able to meet timelines in a fast-paced environment
  • Excellent analytical and problem-solving skills; demonstrated ability to identify and understand complex issues and problems; ability to identify and query key findings from study data and publications.
  • Experience in developing effective abstracts, manuscripts, posters and slides and presenting at scientific meetings
  • Must be fully cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and related Medical Affairs activities; thorough knowledge of FDA regulations, ICH guidelines and GCPs governing the conduct of clinical trials is preferred
  • Able to work with a high level of autonomy and independence.


Display of Gilead Core Values:
  • Integrity (Doing What's Right)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
  • Inclusion (Encouraging Diversity)


We're an equal opportunity employer. Apply online today at www.gilead.com

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