Patient Safety Senior Medical Director

Key Duties And Responsibilities

• Represents department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert input regarding safety matters and issues.
• Conducts medical evaluation of relevant safety-related information from Toxicology, Non-Clinical studies, as well as Product Quality complaints, as needed, demonstrating solid judgment.
• Participates in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
• Participates in the analysis of safety data from on-going and completed clinical trials and its presentation in Clinical Study Reports.
• Provides strategic leadership in the content for periodic reports (DSUR, PSUR) for assigned products.
• Reviews and provides medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charters.
• Provides leadership in pre-, peri- and post-approval Risk Management activities and deliverables, including dRMP, RMPs and product safety labeling, as well as key regulatory engagements, such as Advisory Committee meetings, EU Pre-submission meetings, and Pre-NDA meetings.
• Participates in departmental development activities including SOP and Work Instructions development.
• Provides guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective through leadership of Product Teams.
• Provides timely and sound medical review of individual case safety reports from clinical trials or post-marketing sources.
• As directed by a Disease-area Safety Head, perform due diligence from the perspective of Global Patient Safety for potential in-licensed compounds.
• Provides Global Patient Safety function in Partner /Affiliate agreements and interactions, as needed.
• As directed by a Disease-area Safety Head, serve as Chair of one or more Disease-area Safety Team(s) for assigned products, assuming primary responsibility for the conduct and deliverables of the Teams.
• Participates in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with Vertex signal detection practices.

Knowledge And Skills

• Solid knowledge of GCP, ICH and Global regulations
• Strong knowledge of current Benefit-Risk principles
• Solid written and oral communication skills to communicate highly complex ideas and interact/negotiate with senior leaders
• Solid independent judgment and decision-making skills, including the identification and communication of relevant safety-related issues or concerns to GPS Management in an appropriate and timely manner
• Sound ability to communicate effectively in a matrix environment
• Advanced knowledge of General Medicine
• Advanced experience in the evaluation and interpretation of data
• Advanced experience in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents

Education And Experience

• MD, DO or equivalent ex-US medical degree
• Typically requires 7 years of experience, or the equivalent combination of education and experience