Medical Director, Genetic Medicines

About the role

Lilly Regenerative Medicine (LRM) is seeking a highly motivated and experienced Clinical Research Physician (CRP) to join our Gene Therapy Medical Development function. This role will be instrumental in the clinical development of innovative gene therapies for sensory and rare disorders, contributing to study design, execution, and interpretation of clinical trial data. The CRP will participate in:

• Development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization
• Implementation of global clinical trials
• Reporting of adverse events as mandated by corporate patient safety
• Review of protocols, study reports, publications, and data dissemination materials
• Interactions with regulatory and governmental agencies
• Outreach medical activities aimed at the external clinical customer community, including thought leaders
• Development and implementation of business unit and global strategy for the product
• Medical activities in support of demand realization

The CRP serves as a scientific resource for study teams and departments and ensures compliance with regulations, guidelines (e.g., FDA, ICH, CPMP), Good Clinical Practices (GCPs), company standards, and Lilly policies.

Responsibilities

• Clinical Planning:
  • Collaborate with Discovery to align clinical strategy and plans
  • Maintain up-to-date knowledge of pre-clinical and clinical data relevant to the molecule
• Clinical Research/Trial Execution and Support:
  • Plan, collaborate on, and review scientific content of clinical documents (e.g., protocols, informed consent, final study reports)
  • Provide oversight and input into clinical development plans
  • Collaborate with clinical research staff on trial design, conduct, and reporting
  • Review and approve risk profiles to ensure appropriate communication of risk to study subjects
  • Participate in investigator identification and selection
  • Ensure operational teams complete administrative requirements for study initiation and conduct (e.g., ethical review, regulatory approval)
  • Assist in planning and participate in study start-up meetings and training for investigators and site personnel
  • Serve as a resource for clinical operations personnel, monitors, investigators, and ethical review boards
  • Monitor patient safety during studies and track adverse events per corporate policies
• Scientific Data Dissemination/Exchange:
  • Ensure compliance with laws, regulations, and global policies regarding data dissemination and interactions with healthcare professionals
  • Address unsolicited scientific information needs of external healthcare professionals
  • Participate in Clinical Trial Registry activities
  • Support planning of symposia, advisory board meetings, and other meetings with healthcare professionals
  • Support medical information associates in preparing and reviewing medical letters and materials
  • Support data analysis and development of slide sets and publications (abstracts, posters, manuscripts)
  • Establish and maintain collaborations with external experts and thought leaders
  • Support training of medical personnel, including geographic/affiliate CRPs and global patient outcomes personnel
  • Provide congress support (e.g., answering questions at exhibits, presenting at conferences, meeting thought leaders)
  • Participate in data analysis and preparation of final reports and publications
• Regulatory Support Activities:
  • Participate in development and review of label changes and modifications
  • Provide medical expertise to regulatory scientists
  • Support preparation of regulatory reports (e.g., BLAs, FDA annual reports, advisory committee hearings)
  • Participate in advisory committees and risk management planning
• Business/Customer Support (pre- and post-launch):
  • Contribute to development of medical strategies to support commercialization activities
  • Understand and anticipate scientific information needs of development customers (payers, patients, healthcare providers)
  • Establish and maintain contact with external experts and opinion leaders
  • Contribute as a scientific and medical expert to payer partnership programs and product value defense
  • Support business-to-business and business-to-government activities as a medical expert
  • Contribute to strategic planning for the brand
  • Provide scientific input to development, review, and approval of promotional materials and tactics
  • Define the Patient Journey and act as a patient advocate
• Scientific/Technical Expertise and Continued Development:
  • Critically evaluate relevant medical literature and competitive product data
  • Stay updated with medical and scientific developments in the therapeutic area
  • Responsible for scientific training of the clinical study team
  • Act as a scientific consultant and protocol expert for the clinical study team
  • Explore opportunities for extramural scientific experiences and attend scientific symposia
• General Responsibilities:
  • Set and meet individual professional development goals and contribute to the development of others
  • Support management in preparation and administration of the development budget
  • Participate in recruitment, diversity, and retention efforts
  • Collaborate with alliance, business, and vendor partners
  • Provide timely and constructive feedback to co-workers and the medical team
  • Ensure adequate qualification and training for required tasks
  • Model leadership behaviors and act as an ambassador for patients and the Lilly brand

Requirements

• Medical Doctor (MD) or Doctor of Osteopathy (DO)
• Board eligible or certified in a relevant field, or completed comparable post-medical school clinical training
• For US-trained physicians: board eligibility or certification required
• For non-US trained physicians: must have completed education and training at an LCME-recognized medical school