Associate Medical Director

Associate Medical Director

Location: Cambridge, MA

Duration: 12 Months+ (Possible Extension)

Pay Range: $150 - $170/hr. on W2

Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators, and project team members, and supports business development activities. Provides medical review and analysis for clinical trial serious adverse events, marketed products ICSR, and periodic safety reports (e.g., PBRER, PSUR, DSUR) as well as other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, and CSR).

Essential Functions

• Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
• Ensures tasks delegated to PVG are properly executed.
• Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues.
• Follows client SOPs/directives and project-specific WPDs for assigned projects.
• Complies with PPD corporate policies and SOPs/WPDs.
• Provides medical consultation to team members and answers all study-related medical questions.
• Communicates clearly with associates and clients to ensure procedures are followed appropriately.
• Provides therapeutic and protocol training on assigned studies, as requested.
• Assists in writing or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, ensuring medical content is accurate and complete.

Clinical Trial Support

• Monitors all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medications for protocol restrictions, and un-blinding requests) of clinical studies.
• Discusses medical concerns with principal investigators and clients using proper medical judgment for clinical decision-making.
• Provides medical review of adverse events of special interest, serious adverse events, and clinical outcomes events reported by study sites.
• Performs data review as specified in the client contract and data validation manual, including coding listings and full safety data assessment.

Marketed Products Support

• Manages signal detection activities and scientifically reviews aggregate reports.
• Contributes to label updates, supports dossier maintenance, and risk management activities.
• Medically reviews adverse events and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

Education and Experience

• MD board certified in Neurology.
• At least one of the following:
  • Clinical experience in treating patients in the specialty or sub-specialty (comparable to 2 years).
  • Suitable clinical trial experience in a CRO, pharmaceutical company, or as a principal investigator (comparable to 12 years).
  • Direct experience in safety/Pharmacovigilance (comparable to 2 years).
• Equivalency through a combination of education, training, and directly related experience may be considered.

Knowledge, Skills, and Abilities

• Therapeutic expertise in Neurology.
• Strong decision-making, problem-solving, organizational, and analytical skills.
• Excellent oral and written communication skills.
• Working knowledge of relevant safety databases (e.g., MedDRA).
• Flexibility to travel domestically and internationally (up to 10%).
• Ability to work independently and prioritize sensitive complex information with attention to detail.
• Proficiency in basic computer applications.
• Fluent in spoken and written English.
• Excellent 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 act as a mentor/trainer to other staff.

Comments for Suppliers

• Monday to Friday, usual working schedule 7:0016:00 EST.
• Travel required up to 10% of the time (US or occasional EU).
• Candidate to be based on the East Coast for time-zone alignment.
• Previous industry experience preferred.