Medical Director, Genetic Medicines

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Contribute to the global clinical strategy and clinical plans in partnership with Discovery.

• Stay informed on preclinical and clinical data pertinent to molecules.

• Plan, collaborate on, and review protocols, informed consent documents, final study reports, and regulatory submissions.

• Provide oversight and input on clinical development plans.

• Collaborate in the design, execution, and reporting of local clinical trials.

• Review and approve study risk profiles, ensuring effective risk communication.

• Participate in the identification and selection of investigators.

• Ensure compliance with GCP and local laws regarding study initiation and conduct requirements.

• Engage in study start-up meetings and train investigators and site personnel.

• Act as a resource for clinical operations personnel, monitors, investigators, and ethics boards.

• Monitor patient safety and track as well as follow up on adverse events.

• Support the dissemination of scientific data, including registries, symposia, advisory boards, presentations, analyses, and publications.

• Build relationships with external experts, thought leaders, healthcare professionals, and the medical community.

• Assist in the training of medical personnel and provide support during congress events.

• Participate in label changes, regulatory reports, FDA advisory committee preparation, registration efforts, and regulatory issue resolution.

• Engage in advisory committees and risk management planning.

• Provide medical expertise to commercialization, payer partnership, product value, business-to-business, and business-to-government initiatives.

• Aid in the development and approval of promotional materials.

• Define the Patient Journey and serve as a patient advocate and medical expert.

• Evaluate medical literature, competitive products, clinical practice trends, and access projections.

• Serve as a scientific consultant and protocol expert.

• Set professional development goals and support budgets, recruitment, diversity, retention, coaching, training, and partner collaboration.

• Model leadership behaviors while representing patients and the Lilly brand.

⛳️ Requirements

• Medical Doctor or Doctor of Osteopathy.

• Must be board eligible or certified in a relevant field, or have completed comparable post-medical school clinical training relevant to the hiring country.

• Physicians trained in the US must have achieved board eligibility or certification.

• Non-US trained physicians must have completed education and training at a medical school that meets LCME requirements.

• Experience in gene therapy and/or rare disease Medical Affairs or Patient Advocacy is required.

• A minimum of 3-5 years of experience in clinical research within the pharmaceutical industry or academic research setting.

• Understanding of drug development processes, Good Clinical Practice (GCP), and regulatory requirements.

• Experience with global clinical trials is advantageous.

• Strong scientific acumen and the ability to critically assess clinical data.

• Capability to comprehend and convey complex scientific content clearly and concisely.

• Advanced presentation and computer skills, with expertise in literature identification.

• Demonstrated leadership abilities and the capacity to balance scientific and business priorities.

• Ability to manage multiple priorities and projects effectively.

• Strong communication, interpersonal, teamwork, organizational, and negotiation skills.

• Ability to establish professional relationships and networks.

• Capacity to influence others across functions and within the function.

• Proven ability to work effectively in a multidisciplinary team environment.

• Willingness to travel domestically and internationally as necessary.

• Proficient in English, both verbally and in writing.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• Prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups (ERGs).