Medical Director/Senior Medical Director - Dermatology

Quick Facts

• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office
• Occasional drives to site locations with occasional travel domestic and international

Description

Purpose: Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. 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).

General Support: Ensure tasks delegated to PV are properly executed. Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Follow client SOPs/directives and project-specific WPDs for assigned projects and comply with corporate policies and SOPs/WPDs.

• Provide medical consultation to team members and answer study-related medical questions; communicate clearly with associates and clients.
• Provide therapeutic training and protocol training on assigned studies, as requested.
• Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure medical content is accurate and complete.

Clinical Trial Support: Monitor safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests). Discuss medical concerns with principal investigators and clients (e.g., interpretation of inclusion/exclusion criteria) and provide medical review of adverse events of special interest, serious adverse events, and clinical outcomes events.

• Perform data review per client contract and data validation manual, including review of coding listings and/or full safety data to assess potential safety concerns.

Marketed Products Support: Manage signal detection activities, scientifically review aggregate reports, contribute to label updates, and support dossier maintenance and risk management activities. Medically review adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.

Requirements

• MD or equivalent required
• Active medical licensure preferred
• Candidates should have at least one of the following (comparable experience): clinical experience treating patients in the relevant specialty/sub-specialty (≥ 2 years) OR clinical trial experience in a CRO/pharmaceutical company or as a principal investigator (1–2 years) OR direct experience in safety/Pharmacovigilance (≈ 2 years)
• For Senior Medical Director: combination of clinical experience (≈ 2 years) and either clinical trial industry experience (≈ 1–2 years) or direct safety/Pharmacovigilance (≈ 2 years); equivalency may be considered
• Therapeutic expertise across one or more medical specialties/sub-specialties
• Strong decision-making, problem solving, organizational and analytical skills
• Excellent oral and written communication
• Working knowledge of relevant safety databases (e.g., Medra)
• Flexibility to travel domestically and internationally
• Ability to work independently, analyze complex sensitive information, and prioritize with attention to detail
• Basic computer applications proficiency; fluent spoken and written English
• Understanding of FDA, ICH, EMA and GCP guidelines
• Working knowledge of biostatistics, data management, and clinical operations procedures
• Ability to mentor/trainer other staff within PV

Benefits

Work is performed in an office environment with exposure to electrical office equipment. The role includes occasional drives to site locations and occasional domestic and international travel, and emphasizes employee health and wellbeing supported by resources to create a healthy and balanced environment.