Medical Director – Dermatology

This is a fully remote position, open to applicants in Argentina, +5 more countries.

📋 Description

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

• Participate in and present at meetings with investigators and sponsors.

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

• Assist in business development efforts.

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

• Ensure that tasks assigned to Pharmacovigilance are executed correctly and comply with regulations, ICH guidelines, client directives, and company policies.

• Address study-related medical inquiries and maintain effective communication with colleagues and clients.

• Deliver therapeutic and protocol training for assigned studies.

• Help in drafting and/or reviewing CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, CTD modules, and related deliverables.

• Monitor safety variables, including adverse events, laboratory abnormalities, patient medical status, concomitant medication restrictions, and unblinding requests.

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

• Review adverse events of special interest, serious adverse events, and clinical outcome events.

• Conduct data reviews, including coding listings and/or comprehensive safety data, to identify potential safety issues.

• Oversee signal detection activities and scientifically assess aggregate reports.

• Contribute to label updates, dossier maintenance, and risk management initiatives.

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

⛳️ Requirements

• MD or equivalent is required.

• Active medical licensure is preferred.

• Clinical experience in the relevant specialty or sub-specialty, approximately 2 years.

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

• Alternatively, direct experience in safety/Pharmacovigilance, approximately 2 years.

• For Senior Medical Director: clinical experience of about 2 years plus suitable clinical trial experience of approximately 1–2 years or direct safety/Pharmacovigilance experience of around 2 years.

• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered.

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

• Familiarity with relevant safety databases (e.g. MedDRA).

• Willingness to travel domestically and internationally.

• Proficient in basic computer applications.

• Fluent in both spoken and written English.

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

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

• Capability to mentor and train other staff within Pharmacovigilance.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Opportunities to contribute to meaningful work and life-changing therapies.

• Career development resources and support.

• Occasional domestic and international travel.