Director – Medical, Clinical Research Physician
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Job Description
Clinical Research Physician leading early-phase global trials for Lilly’s cardiometabolic and women’s health medicines. Guiding clinical strategy, safety, regulatory submissions, and scientific data dissemination.
Responsibilities:
- Participate in development, conduct and reporting of global clinical trials for compounds in the cardiometabolic research therapeutic area, including women’s health
- Support implementation of global clinical trials and report adverse events according to corporate patient-safety requirements
- Review protocols, study reports, publications, data dissemination, labels, grant submissions, contracts, and regulatory interactions
- Assess licensing opportunities and conduct outreach to external clinical customers
- Work with research scientists to identify lead compounds and clinical candidates and plan pre-clinical studies
- Provide internal training, peer review of clinical protocols and reports, and ad hoc scientific consultation
- Work with late-stage development colleagues to plan clinical studies, outcomes research, and pharmacoeconomic research
- Contribute to clinical development strategy and plans for early-phase compounds
- Collaborate on design, conduct and reporting of Phase Ib and IIa/IIb trials
- Integrate clinical studies with PK/PD, statistics, molecular epidemiology, ADME, modeling and simulation approaches
- Design and write clinical trial protocols and oversee study implementation
- Collaborate with investigators, consultants, clinical research staff, statisticians and health outcomes researchers
- Monitor patient safety and track and follow up adverse events
- Support clinical trial data analysis, reporting, publications, presentations, symposia and advisory boards
- Support regulatory reports, IND and Investigator Brochure medical sections, FDA advisory committee hearings, labeling modifications and risk management planning
- Provide medical expertise to regulatory scientists and business units
- Advise on potential markets for development and licensed compounds and support business development
- Build relationships with external experts, thought leaders, professional societies and the medical community
- Participate in patent development and define the Patient Journey and Moments of Truth
- Maintain current knowledge of medical literature, clinical practice, pre-clinical and clinical data, and therapeutic-area developments
- Set professional development goals, coach colleagues, participate in recruitment and retention efforts, and lead matrixed cross-functional teams
Requirements:
- Medical Doctor or Doctor of Osteopathy
- Must be board eligible or certified in a medical specialty, or have completed comparable post-medical-school clinical training relevant to the country of hiring
- U.S.-trained physicians must have achieved board eligibility or certification
- Non-US-trained physicians must have completed education and training at a medical school meeting LCME requirements
- Fluent in English, both written and verbal
- Interpersonal, organizational and negotiation skills
- Ability to influence others cross-functionally and within the function
- Excellent teamwork skills
- Willingness to engage in domestic and international travel as appropriate
- Board certified or eligible in Obstetrics and Gynecology preferred
- Clinical research or pharmaceutical medicine experience preferred
- Knowledge of drug development process preferred
Benefits:
- Company bonus depending partly on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision and 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 employee assistance program, fitness benefits, and employee clubs and activities
- Employee resource groups offering support networks
- Disability accommodation support during the application process
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