Director – Clinical Pharmacologist, Clinical Research Physician

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

📋 Description

• Advance several early clinical assets into first-in-human trials or assist in their further development through clinical pharmacology and mechanistic studies.

• Design, execute, and report on global clinical trials for new compounds.

• Implement global clinical trials and document adverse events in accordance with corporate patient-safety standards.

• Examine protocols, study reports, publications, data dissemination, product labels, grant submissions, contracts, and regulatory documents.

• Engage with external clinical clients and thought leaders.

• Ensure that medical team operations adhere to local and international regulations, FDA, ICH, CPMP, GCPs, company guidelines, and Lilly policies.

• Collaborate with basic research scientists to plan pre-clinical studies and develop biomarker strategies.

• Act as a scientific and medical resource for study teams and departments.

• Contribute to strategies and plans for the clinical development of compounds.

• Assist in preparations for first-in-human dosing, Phase 2 and 3 planning, and biopharmaceutical submission planning.

• Work together with Global Patient Safety, PK/PD, ADME, Statistics, Tailored Therapeutics, and quantitative science teams.

• Collaborate with discovery research scientists on research strategies, candidate selection, and pre-clinical development.

• Partner with Brand Team and Business Unit colleagues on market differentiation and regulatory support.

• Design and supervise clinical pharmacology, mechanistic, development, and biomarker qualification studies.

• Create protocols and study conduct documents in compliance with GCP and local regulations.

• Work alongside clinical research staff, statisticians, health outcomes scientists, consultants, and investigators.

• Take part in the identification and selection of investigators.

• Review risk profiles and informed consent documents.

• Oversee ethical review, informed consent, regulatory approval/notification, study initiation, training, and site activities.

• Provide guidance to clinical trial managers, monitors, investigators, and ethical review boards during studies.

• Monitor patient safety, track and follow up on adverse events, and implement pharmacovigilance measures.

• Provide oversight and collaboration with third-party organizations for study execution.

• Address scientific inquiries from external healthcare professionals.

• Participate in clinical trial registry reporting, publication strategy, scientific communications, data analysis, final reports, and publications.

• Present clinical trial findings to corporate committees, regulatory bodies, and external agencies.

• Prepare clinical and regulatory reports, including medical sections of INDs and Investigator Brochures.

• Support FDA advisory committee hearings, label discussions, and resolution of regulatory issues.

• Develop and maintain a scientifically proficient workforce while promoting inclusion, innovation, and continuous improvement.

• Assist in commercialization and medical strategies with business units, New Product Planning, and business development.

• Cultivate relationships with external experts and opinion leaders.

• Support business-to-business and business-to-government initiatives as a medical expert.

• Contribute to ongoing strategic brand planning while understanding market archetypes.

⛳️ Requirements

• Medical Doctor (M.D.) or Doctor of Osteopathy (D.O.).

• Non-U.S. trained physicians must have completed their education and training at a medical school recognized by the Liaison Committee on Medical Education (LCME).

• Must be board eligible or certified in an appropriate specialty/subspecialty, or have completed equivalent post-medical-school clinical training relevant to the hiring country.

• U.S.-trained physicians must have achieved board eligibility or certification.

• Minimum of two years of experience in the pharmaceutical industry or a similar field relevant to Phase 1 and Phase 2 clinical trial design and execution.

• Familiarity with clinical programs, trials, and/or protocols, statistical/inferential methods, biomarkers/rating instruments, regulatory standards, safety evaluations, and investigator/site management.

• Proficient in English, both written and spoken.

• Willingness to participate in domestic and international travel, approximately 10–15%.

• Proven strong communication, interpersonal, organizational, teamwork, and negotiation skills.

• Demonstrated ability to influence others within teams and matrix environments.

• Additional scientific training or degree (M.S., Ph.D.) is preferable.

• Experience in a pharmaceutical company is preferable.

• Clinical and/or research experience in endocrinology, diabetes, obesity, cardiovascular, or renal research is preferable.

• Experience in Clinical Pharmacology is preferable.

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k).

• Pension plan.

• Vacation benefits.

• Medical, dental, vision, and prescription drug coverage.

• 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 programs, fitness benefits, and employee clubs and activities.

• Employee resource groups available to all employees.

• Disability accommodation assistance during the application process.