Benefit-Risk Management Scientist

4 weeks ago

Indianapolis, United States Eli Lilly and Company Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Benefit-Risk Assessment (B-RA) at Lilly utilizes a structured, transparent framework to increase the transparency, predictability and consistency to enhance B-RA decision making. The Benefit-Risk Management Scientist (BRMS) is responsible for benefit-risk assessment, consultation, and policy issues across the lifecycle of Lilly drugs. Working closely with the GPS Benefit Risk Lead and the GPS Safety Science Sr. Director, the BRMS is responsible for development of scientific standards, best practices, study plans, and scientific tools to facilitate B-RA for Lilly compounds in early development, peri- and post- approval.  In addition, the BRMS will work collaboratively with other functions, such as Value, Evidence and Outcomes (VEO), Real World Evidence (RWE), Inc., Global Regulatory Affairs (GRA), Medicines Development Unit (MDU), regional/affiliate medical and Business Unit (BU) teams, alliance partners, and third-party organizations to implement B-RA.

The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Technical Benefit-Risk Expertise

  • Develop and maintain a systematic B-RA framework suitable for inclusion in strategic planning and regulatory interactions for Lilly drugs throughout the lifecycle.
  • If and when quantitative B-RA is used, such as multi-criteria decision analytic methods , BRMS may develop clinical assessment protocols for benefits and safety attributes as needed.
  • Develop, assess, and implement analytic tools for use in B-RA, as appropriate, including:

    Qualitative and quantitative approaches to B-RA.

    Creation of B-RA visualizations for multi-stakeholder communication.

    • Develop and ensure the utilization and consistency of documented process and quality system for systematic B-RA in partnership with the Benefit Risk Lead.
    • Provide B-RA and risk education training to stakeholders as needed.
    • Serve as a consultant in the design, development, and use of scientific methods and tools for optimizing the benefit-risk profile (e.g. Labeling, Risk Assessment, Risk Minimization, Risk Communication).

      Application of B-RA to the Lilly portfolio

      • Facilitate cross-functional BU team discussions during the development of systematic B-RA according to the single process map.
      • Plan and develop recommendations for systematic benefit-risk assessment, according to the single process map.
      • Provide benefit-risk consultation and support to BU teams, and disseminate technical information through technical reports, presentation, and publication in peer-reviewed literature as agreed by the team and/or GPS.
      • Communicate effectively with relevant internal partners, including Safety Management Teams and GPS Surveillance, among other cross-functional GPS and  BU team members.
      • Guide and collaborate with third party vendors as needed to develop effective B-RA competencies and capacity.

        External Influence

        • Represent Lilly on selected external B-RA working groups as required to understand and influence the global external environment.
        • Maintain awareness of developing and ongoing initiatives (policies, practices, guidance, and regulations) at the FDA, EMA, and other regulatory agencies as it relates to B-RA.

          Support of EU QPPV

          • Understand the role of the EU Qualified Person for Pharmacovigilance (QPPV).
          • Support the EU QPPV to fulfill his/her legal responsibilities.

            Minimum Qualification Requirements:  

            • Advanced clinical degree – Masters or Doctorate (e.g. PharmD, PhD, MD, MPH) with:
            • 3 years scientific experience in epidemiology, program evaluation, health behavior, health education and/or clinical development.
            • 2 years' experience supporting regulatory submissions to FDA/EMA with focus on analytic review and/or clinical study protocol review.

              Or

            • Advanced clinical degree – Masters or Doctorate (e.g. PharmD, PhD, MD, MPH):
          • Successful completion of the Visiting Scientist Fellowship (VSF)/Lilly Post Doc Program/Lilly Fellow Program

            Other Information/Additional Preferences:  

          • Ability to understand and communicate various aspects of delivery of healthcare (e.g. clinical settings, payer, comparative treatments).
        • Demonstrated leadership skills including strong decision-making and the ability to negotiate and influence internally and externally.
      • Experience in developing and execution of benefit-risk assessments of medical products.
    • Experience in epidemiology and public health in the pharmaceutical industry.
  • Experience in statistical analysis.
Experience with risk management programs and activities.Demonstrated ability to learn quickly.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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