Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionJob SummaryThe Executive Medical Director provides advanced medical and strategic leadership within the Pharmacovigilance (PV) physician organization. This role may include direct line management responsibilities and serves as a key liaison between PV physicians, PV leadership, cross-functional teams, and clients.
The Executive Medical Director provides leadership and strategic direction across pharmacovigilance, medical monitoring, quality and compliance, process improvement, training and development, business objectives, and innovation. The role applies therapeutic area and indication-specific expertise to provide medical consultation, guide benefit-risk evaluation and risk mitigation strategies, and support clinical development and business development activities.
This position may manage, mentor, and provide oversight to PV physicians globally, supporting end-to-end medical monitoring and safety physician activities throughout the pharmaceutical product lifecycle. The Executive Medical Director also contributes to resource planning, budget management, operational strategy, and continuous improvement initiatives.
Key Responsibilities- Provides global and regional medical leadership, mentoring, and oversight to PV physicians and, where applicable, direct reports.
- Serves as a senior medical and pharmacovigilance subject matter expert and represents the PV physician organization on significant internal and external matters.
- Applies clinical, therapeutic area, and pharmacovigilance expertise to the interpretation of safety and efficacy data, benefit-risk evaluation, safety signal assessment, risk mitigation, and clinical trial data interpretation.
- Provides strategic medical oversight of clinical trial serious adverse events, aggregate safety data, individual case safety reports, periodic safety reports, signal detection activities, risk management plans, labeling activities, and other client deliverables.
- Establishes relationships with key decision-makers and collaborates with cross-functional leaders on strategic initiatives, process improvements, and training and development programs.
- Provides leadership on quality and regulatory compliance matters and serves as a subject matter expert during audits and inspections.
- Identifies significant medical monitoring and safety issues and develops appropriate prevention, mitigation, and corrective strategies.
- Supports business development activities, including strategy discussions, proposal development, bid reviews, and development of parameters for business deliverables.
- Provides global leadership for medical safety and risk mitigation activities and develops strong client relationships.
- Provides medical expertise and oversight for study start-up activities and medical deliverables.
- Partners with sponsors to obtain direction and feedback regarding program scope, deliverables, and performance.
- Participates in recruitment and selection activities.
- Where applicable, manages employee onboarding, performance management, compensation administration, development, promotion, employee relations, and conflict resolution.
- Develops and manages resource allocation plans and budgets.
- Maintains an understanding of contracts, budgets, project time allocation, and related operational requirements.
- Builds a collaborative, accountable, and high-performing team environment focused on quality, delivery, and continuous improvement.
Education and Experience- MD or equivalent medical degree required.
- History of an active medical license highly preferred.
- Typically requires 12+ years of relevant professional experience providing the knowledge, skills, and abilities necessary to perform the role.
- Minimum of 2 years of clinical experience treating patients as a psychiatrist with direct responsibility for diagnostic and treatment decisions.
- Minimum of 5 years of clinical trial experience within a CRO, pharmaceutical company, or as an industry principal investigator.
An equivalent combination of appropriate education, training, and directly related experience may be considered.
Knowledge, Skills, and Abilities- Deep therapeutic and indication-specific drug development expertise across one or more therapeutic areas and/or drug classes.
- Strong knowledge of clinical development programs, study design, endpoints, safety considerations, and the regulatory and commercial landscape.
- Deep understanding of regulatory requirements governing adverse event reporting and experience working with the FDA, EMA, and other national and international regulatory authorities.
- Demonstrated experience providing medical strategy leadership to multidisciplinary teams.
- Extensive knowledge of medical monitoring, including adverse event review, protocol inquiries, listings, diagnostic reports, data trending, and related activities.
- Strong knowledge of pharmacovigilance activities, including signal detection, aggregate reporting, labeling updates, dossier maintenance, and risk management.
- Thorough understanding of marketing authorization submission requirements and international clinical study guidelines.
- Strong decision-making, negotiation, analytical, communication, and influencing skills.
- Demonstrated ability to lead, mentor, develop, and objectively evaluate medical professionals.
- Excellent organizational skills with a detail-oriented leadership approach.
- Strong knowledge of the overall drug development lifecycle.
- Ability to work independently, manage multiple priorities, and operate effectively in a fast-paced global environment.
- Ability to travel domestically and internationally as required.
Working Conditions and Environment:- Work is performed in an office environment with exposure to electrical office equipment.
- Occasional driving to site locations and occasional domestic and international travel.
Physical Requirements:- Frequently stationary for 6-8 hours per day.
- Repetitive hand movements, including the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending, and twisting of the upper body and neck.
- Light to moderate lifting and carrying of objects, including luggage and laptop computers, up to 15-20 lbs.
- Ability to access and use a variety of computer software, including both internally developed and commercially available applications.
- Ability to communicate information and ideas clearly and to understand information presented through spoken words and sentences.
- Frequent interaction with diverse groups to obtain and communicate information.
- Ability to work independently with minimal guidance, plan work schedules to meet goals, and maintain concentration for extended periods.
- Ability to perform a wide range of tasks in response to changing demands and conditions, manage multiple priorities, and perform effectively under pressure.
- Regular and consistent attendance.
