Senior Medical Director – Endocrinology

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

📋 Description

• Oversee the medical aspects of clinical trials to guarantee adherence to SOPs, client directives, GCP, 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 of serious adverse events, marketed-product ICSR, and periodic safety reports.

• Manage the medical components of contracted tasks throughout the pharmaceutical product lifecycle.

• Ensure that pharmacovigilance activities are executed correctly and comply with regulations, ICH guidelines, client SOPs, and project procedures.

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

• Provide training on therapeutic areas and protocols.

• Draft or review Clinical Study Reports (CSRs), IND/NDA reports, Individual Case Safety Reports (ICSRs), signal detection reports, periodic reports, Risk Management Plans (RMPs), Risk Evaluation and Mitigation Strategies (REMS), CTD modules, and related deliverables.

• Monitor safety indicators in clinical trials, including adverse events, laboratory abnormalities, medical-status changes, concomitant medications, and unblinding requests.

• Engage in discussions regarding medical issues with principal investigators and clients, making clinical decisions related to investigational studies.

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

• Conduct contracted data reviews and evaluate potential safety concerns.

• Manage signal detection, review aggregate reports, assist with label updates, and support dossier maintenance and risk management activities.

• 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.

• For Medical Director: a clinical background treating patients in the relevant specialty or sub-specialty for about 2 years; or equivalent clinical trial experience of 1–2 years; or direct safety/Pharmacovigilance experience for around 2 years.

• For Senior Medical Director: a clinical background in the relevant specialty or sub-specialty for approximately 5 years, along with suitable clinical trial experience of 4–5 years or direct safety/Pharmacovigilance experience of 5 years.

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

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

• Familiarity with relevant safety databases, such as MedDRA.

• Willingness to travel domestically and internationally.

• Proficiency in spoken and written English.

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

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

• Proficiency in basic computer applications.

• Ability to work independently and handle complex, sensitive information.

• Strong decision-making, problem-solving, organizational, and analytical capabilities.

• Excellent oral and written communication skills.

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

• Ability to mentor and train other staff within Pharmacovigilance.

🏝️ Benefits

• Global team environment.

• Resources available to help achieve individual career objectives.

• Opportunities for collaboration and professional development.

• Support for health and wellbeing.

• A healthy and balanced work environment.

• A workplace focused on scientific excellence.