Has direct line management accountability for junior staff. Manages and mentors assigned staff to support end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life-cycle. Serves as a medical strategy leader to multidisciplinary teams within Pharmacovigilance. Applies deep therapeutic area and indication-specific knowledge to provide strategic direction and risk mitigation strategies to internal teams. Provides medical review and analysis of clinical trial serious adverse events & marketed products ICSRs, signal detection activities and contributions to periodic safety reports, as well as, other client deliverables. Ensures company SOPs, client directives and regulatory requirements are followed. Attends and presents at investigator and sponsor/client meetings, provides medical consultation to clients, investigators and project team members and supports business development activities. In addition to direct line management activities, Senior Medical Directors may have task-specific specialized areas of focus.
- Provides leadership to direct reports by cultivating a supportive, motivating and collaborative work environment.
- Management responsibilities include onboarding, salary administration, performance management including promotion and discharge activities, conflict resolution, recruiting and mentoring for direct reports.
- Assists direct reports as needed with sponsor communication and provides direction and feedback on implementing scope of work.
- Assists and oversees direct reports with study startup activities.
- Identifies unusual or significant project related concerns encountered for self or a direct report and proposes strategies for preventing or correcting significant problems.
- Attends MD management calls as well as regional physician calls.
- Maintains understanding of contracts and budgets, project billing, expense submission and travel.
- Presents CRG standard medical/safety processes to prospective clients at business development meetings, and communication with medical communities to explore and expand CRG business. This includes participation in business development opportunities (e.g. networking) at educational conferences and meetings.
- Collaborates with bidders in establishing parameters for business deliverables.
- Participates in strategy calls, proposal development and bid reviews.
- May engage in and provides oversight for assigned strategic partnership medical leadership relationships.
- Provides regional leadership and participates on cross-functional enterprise initiatives.
- Manages all medical aspects of contracted tasks across the pharmaceutical product life-cycle.
- Ensures tasks delegated to PV are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to CRG’s corporate policies and SOPs/WPDs.
- Provides medical consultation to team members and answer all study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.
- Provides therapeutic training and protocol training on assigned studies, as requested.
- Assists in writing (interpretation of safety and efficacy data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the 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 medication for protocol restrictions, and un-blinding requests) of clinical studies.
- Discusses all medical concerns with principal investigators and clients (e.g. discussion regarding interpretation of inclusion/exclusion criteria) raised during the course of a study, using proper medical judgment in the interpretation and decision making with regard to clinical situations as they relate to the investigational study.
- 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 review of coding listings and/or full safety data to assess for potential safety concerns.
Marketed Products Support
- Manages signal detection activities, generates aggregate reports, contributes to label updates, supports dossier maintenance and risk management activities.
- Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc.) as contracted.
Education and Experience
- MD or equivalent required. Active medical licensure preferred. Candidates should have a combination of clinical experience and industry experience as follows:
- Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years) and one of the following.
- Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 6 years) in the industry; Or
- Direct experience in safety/Pharmacovigilance (comparable to 6 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities
- Therapeutic and indication-specific development expertise across one or more therapeutic areas and/or one or more drug classes, including deep knowledge of clinical program and study design, relevant endpoints, safety considerations, and current regulatory and commercial landscape.
- Deep knowledge of important regulatory considerations governing adverse event reporting and experience with FDA, EMA and other national and international regulatory authorities.
- Experience as a medical strategy leader for multidisciplinary teams with mastery of medical management tasks (review AEs, protocol inquiries, listings, diagnostic reports, etc.) and/or safety tasks (signal detection activities, aggregate report generation, label update contribution, dossier maintenance support, and risk management activities).
- Thorough understanding of guidelines for marketing authorization submissions and international guidelines for conduct of clinical studies.
- Strong decision-making, negotiation and analytical skills.
- Excellent communication and influencing skills.
- Excellent organizational skills and detail-orientated leadership approach.
- Ability to tactfully supervise and objectively evaluate assigned staff.
- Ability to mentor effectively in both one-on-one and in group settings.
- Flexibility to travel domestically and internationally.
- Ability to work independently on multiple tasks in a fast-paced environment.
- Proficient in basic computer applications.
- Overall knowledge of the drug development process.
- Ability to effectively manage direct reports, budgets and resources.