Director, Medical – Clinical Research Scientist

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

📋 Description

• Engage in the development, execution, and reporting of global clinical trials for new compounds.

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

• Evaluate protocols, study reports, publications, data dissemination, product labels, grant proposals, and contracts.

• Collaborate with regulatory and governmental agencies.

• Analyze licensing opportunities and reach out to the external clinical customer community.

• Partner with research scientists to identify lead compounds and clinical candidates while planning pre-clinical studies.

• Provide internal training, peer reviews of clinical protocols and reports, and ad hoc scientific consultation.

• Design clinical studies, outcomes research, and pharmacoeconomic research to address patient needs.

• Formulate clinical strategies and plans for compounds, including Phase III planning.

• Create and manage Phase Ib and Phase IIa/IIb clinical studies and draft clinical trial protocols.

• Work alongside clinical research staff, investigators, statisticians, quantitative scientists, pharmacologists, and other cross-functional collaborators.

• Oversee study initiation, regulatory approvals, ethical reviews, informed consent processes, training, monitoring, and patient safety.

• Engage in data analysis, clinical trial registry reporting, final reports, publications, presentations, symposia, advisory boards, and congress events.

• Assist with regulatory reports, IND and Investigator Brochure medical sections, FDA advisory committee hearings, labeling modifications, and risk management planning.

• Offer medical and scientific counsel to business units, payers, patients, healthcare providers, marketing, and management.

• Build relationships with external experts, thought leaders, professional societies, and the broader medical community.

• Take part in business development, patent development, committees, initiatives, task forces, recruitment, diversity, and retention efforts.

• Lead cross-functional teams and represent both the patient and Lilly brand.

• Stay updated on medical literature, clinical practice, preclinical and clinical data, and scientific advancements.

⛳️ Requirements

• PhD in a relevant field, such as Development Biology, Immunology, Cell Biology, Physiology, Pharmacology, or Neuroscience.

• Over 5 years of experience in clinical development.

• Experience in clinical research or pharmaceutical medicine is preferred.

• Familiarity with the drug development process is advantageous.

• Proficient in English, both written and spoken.

• Strong interpersonal, organizational, and negotiation abilities.

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

• Exceptional teamwork skills.

• Willingness to travel domestically and internationally as needed to support the team's business objectives.

🏝️ Benefits

• Company bonus based, in part, on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension benefits.

• 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.

• Various time off and leave of absence benefits.

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

• Support for disability accommodations during the application process.

• Access to employee resource groups and support networks.