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Senior Director, Medical Affairs - Evidence Generation

United States - California - Santa MonicaMedical AffairsRegular

Job Description

Senior Director, Evidence Generation assists in developing and implementing strategy for clinical research. The Director works cross-functionally to content expertise and tactical support for the execution of evidence generation across the portfolio.

Responsibilities

  • Develop a deep understanding of internal and external stakeholders needs by identifying evidence gaps in line with Kite product strategies
  • Demonstrate a thorough understanding of RWD sources to guide the organization on appropriate data sources to use for addressing key business questions
  • Lead the development of a Global and US medical evidence plan in close cross-functional collaboration and in close alignment with cross-functional teams (Global Medical Affairs, Clinical Development, Biometrics, Value and Access, and Translational science teams)
  • Ensure organized and timely execution and completion of projects included in the evidence plan
  • Coordinate the procurement of various specific datasets, design and implement analytical solutions in support of various business strategies e.g. understanding of current treatment landscape, burden of disease, unmet need based on RWD sources
  • Ensure findings are communicated effectively, and as appropriate in conference presentations, publications, dossiers, and other means
  • Thoughtful vendor management in line with our needs. Ensuring vendors act in line with all applicable standards, rules, and regulations
  • Monitor the external environment to stay up to date on leading analytic capabilities, both within and outside of pharma, which can be applied within the organization
  • Guide and support the US Medical field team when Investigator Initiated Trial (IIT) proposals are received to ensure proposals of high quality and in line with strategy
  • Support the dialogue with Global Medical Affairs team in close collaboration with the field team
  • Serve as a link between Global Medical Affairs, Clinical Development and Market access and commercial teams in development of evidence strategies and tactics
  • Responsible for budget development and planning including assessing cost and ensure return of investment. Furthermore, ensure cost control and strategic use of budget related activities within the scope of the role.
  • Provide strategic support and work closely with Medical Science Liaisons (MSLs), participation and insight in MSL activities, such as KOL interactions
  • Provide medical support as needed on company and non-company sponsored studies, non-interventional studies and investigator sponsored studies

Basic Qualifications

Advanced scientific degree (i.e. MD, PharmD, PhD) and 10+ years of observational research study management or data analytics experience

OR

Master’s Degree and 12+ years of observational research study management or data analytics experience

OR

Bachelor’s Degree and 14+ years of observational research study management or data analytics experience

Preferred Qualifications

  • PhD in biostatistics, epidemiology, health economics and outcomes research, health policy, or similar
  • Formal training in Epidemiology/Health Services Research
  • 5+ years of experience in observational research study management and data analytics, either within industry or with an observational research consulting firm
  • 10 + years pharma experience including Oncology or Hematology
  • Demonstrated capabilities in development of medical evidence strategies, tactics, and proven track record of impactful execution of Evidence plans in pre-launch and launch phase
  • Proficiency in data generation including non-interventional studies and real-world evidence studies
  • Good understanding of clinical trial development
  • Strong organizational skills and time management; ability to manage diverse range of simultaneous projects
  • Demonstrated ability to act as an informal leader in an international, highly multicultural matrix organization
  • Solid collaboration and teamwork inter-personal characteristics including excellent verbal and written communication skills
  • Innovative mindset with ability to solve for problems through creative thinking
  • Ability to work in an agile fast-moving environment
  • Pro-active and goal oriented with the ability to act independent
  • Always keep high ethical standards and acting compliant to applicable rules and regulations
  • Current GCP Training