Medical Director – Dermatology

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

📋 Description

• Oversee the medical aspects of clinical trials to ensure adherence to SOPs, client directives, good clinical practice, and regulatory standards.

• Participate in and deliver presentations at investigator and sponsor meetings.

• Offer medical consultation to clients, investigators, project team members, and associates.

• Assist in business development initiatives.

• Conduct medical reviews and analyses for serious adverse events in clinical trials, marketed-product ICSRs, periodic safety reports, and other client deliverables.

• Ensure that tasks assigned to Pharmacovigilance are executed properly.

• Adhere to relevant regulations, ICH guidelines, client SOPs/directives, project WPDs, and corporate policies.

• Deliver therapeutic and protocol training for assigned studies.

• Contribute to the writing and/or reviewing of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related documentation.

• Monitor safety variables, including adverse events, laboratory abnormalities, changes in patient medical status, concomitant medications, and un-blinding requests.

• Engage in discussions regarding medical concerns with principal investigators and clients, applying medical judgment to clinical study decisions.

• Review adverse events of special interest, serious adverse events, and clinical outcomes reported by study sites.

• Perform data review and validate coding listings/full safety data to evaluate safety concerns.

• Manage signal detection activities and scientifically assess aggregate reports.

• Contribute to updates of labels, maintenance of dossiers, and risk management activities.

• Medically review adverse-event and serious-adverse-event data from solicited, spontaneous, literature, and other sources.

⛳️ Requirements

• MD or equivalent degree is required.

• Active medical licensure is preferred.

• Clinical experience in the relevant specialty or sub-specialty comparable to 2 years.

• Alternatively, suitable clinical trial experience in a Contract Research Organization, pharmaceutical company, or as a principal investigator, comparable to 1–2 years.

• Or direct experience in safety/Pharmacovigilance equivalent to 2 years.

• For Senior Medical Director: clinical experience comparable to 2 years plus relevant clinical trial experience of 1–2 years or direct safety/Pharmacovigilance experience equivalent to 2 years.

• Therapeutic expertise in one or more medical specialties or sub-specialties.

• Strong skills in decision-making, problem-solving, organization, and analysis.

• Excellent verbal and written communication abilities.

• Familiarity with relevant safety databases, such as MedDRA.

• Willingness to travel domestically and internationally.

• Capability to work independently and analyze and prioritize sensitive, complex information.

• Proficiency in basic computer applications.

• Fluency in spoken and written English.

• Strong interpersonal, influencing, and team-building skills.

• Understanding of FDA, ICH, EMA, and GCP guidelines.

• Working knowledge of biostatistics, data management, and clinical operations procedures.

• Ability to mentor and train other staff within Pharmacovigilance.

• In some instances, a combination of appropriate education, training, and/or directly related experience may be considered.

🏝️ Benefits

• Resources available to help achieve individual career objectives.

• Support for a healthy and balanced work environment.

• Opportunities for mentoring and training.