Director – Medical, Clinical Research Physician

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

📋 Description

• Engage in the development, execution, and reporting of global clinical trials within the cardiometabolic research therapeutic area, including women's health.

• Assist in the implementation of global clinical trials and document adverse events in compliance with corporate patient-safety standards.

• Review study protocols, reports, publications, data dissemination, labels, grant applications, contracts, and interactions with regulatory bodies.

• Evaluate licensing opportunities and reach out to external clinical customers.

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

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

• Partner with late-stage development teams to strategize clinical studies, outcomes research, and pharmacoeconomic research.

• Contribute to the clinical development strategy and plans for early-phase compounds.

• Collaborate on the design, execution, and reporting of Phase Ib and IIa/IIb trials.

• Integrate clinical studies with pharmacokinetics/pharmacodynamics, statistics, molecular epidemiology, ADME, and modeling and simulation techniques.

• Create and draft clinical trial protocols and oversee the implementation of studies.

• Collaborate with investigators, consultants, clinical research personnel, statisticians, and health outcomes researchers.

• Monitor patient safety and track adverse events, ensuring appropriate follow-ups.

• Aid in clinical trial data analysis, reporting, publications, presentations, symposia, and advisory boards.

• Assist in regulatory reports, including 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 while supporting business development efforts.

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

• Take part in patent development and define the Patient Journey and Moments of Truth.

• Stay updated with the latest medical literature, clinical practices, pre-clinical and clinical data, and advancements in the therapeutic area.

• Set professional development objectives, mentor colleagues, participate in recruitment and retention initiatives, and lead cross-functional teams.

⛳️ Requirements

• Medical Doctor or Doctor of Osteopathy degree.

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

• U.S.-trained physicians are required to achieve board eligibility or certification.

• Non-U.S.-trained physicians must have completed their education and training at a medical school that meets LCME standards.

• Proficiency in English, both written and spoken.

• Strong interpersonal, organizational, and negotiation skills.

• Capability to influence others both cross-functionally and within the department.

• Demonstrated teamwork skills.

• Willingness to travel domestically and internationally as necessary.

• Board certification or eligibility in Obstetrics and Gynecology is preferred.

• Experience in clinical research or pharmaceutical medicine is preferred.

• Familiarity with the drug development process is preferred.

🏝️ Benefits

• Company bonus based partly on individual and company 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.

• Paid time off and leave of absence benefits.

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

• Employee resource groups providing support networks.

• Disability accommodation assistance during the application process.