Medical Director, Global Drug Safety

The Medical Director, GDS&RM will perform individual and aggregate case reviews and provide broad support of activities requiring medical safety input for assigned products, both pre- and post-approval. The Medical Director, GDS&RM will support and/or lead periodic safety signaling reviews and meetings. This position will also participate, to varying degrees, on clinical teams/programs and other intra- and interdepartmental activities and initiatives, as needed.

Responsibilities

Provide timely and scientifically sound medical review of individual case safety reports from clinical trials and post-marketing sources; Serve as the GDS&RM medical expert for SAE reconciliation, coding reviews, and assessment of the expectedness of serious adverse reactions (SARs); Represent the department as the medical safety lead on cross-functional study and program teams for assigned products and studies; Represent the department as the subject matter expert (SME) during audits and inspections; Participate in protocol development, specifically regarding the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans; Conduct safety signal detection activities, including monitoring, evaluation, interpretation, management, and communication of safety information to the Safety Surveillance/Safety Management Team for assigned products; Collaborate closely with Clinical Medical Monitors on ongoing safety monitoring and participate in the analysis of safety data from ongoing and completed clinical trials, including contributions to Clinical Study Reports; Work closely with the Medical Affairs team on post-approval product safety reports, investigator-sponsored trials (ISTs), and compassionate-use programs; Oversee the appropriate review of all safety data from various sources throughout the development process for assigned products; Author Safety Assessment Reports and other safety-related documents and regulatory responses; Contribute to the preparation and review of periodic reports such as IND Annual Reports, DSURs, PSURs, and CSRs; Review and provide medical input for key study-related documents including Investigator's Brochures, Informed Consent Forms, and IDMC Charters; Participate in departmental development activities, including the creation and revision of SOPs and Work Instructions; Provide medical guidance to staff regarding best practices for the collection, evaluation, and processing of adverse event reports; Contribute to partner and affiliate agreements and interactions; Assume primary responsibility for and/or chair one or more Safety Teams for assigned products; Participate in Risk Management Strategy activities; Perform other duties as assigned by management

Requirements

MD, DO or equivalent non-US medical degree; Strong knowledge of general medicine and clinical medical practice (MD, DO, MBBS, or equivalent); Strong understanding of disease pathophysiology and medical therapies; Working knowledge of GCP, ICH guidelines, and global regulatory requirements; Minimum of 5 years of experience in Drug Safety/Pharmacovigilance or as a Medical Monitor; Experience in the evaluation, analysis, and interpretation of safety data; Demonstrated ability to manage multiple priorities and responsibilities; Strong written and verbal communication skills; Sound judgment and decision-making abilities, including the timely identification and communication of relevant safety issues and concerns to Medical Safety Management; Experience reviewing AEs/SAEs, Investigator's Brochures, protocols, Clinical Study Reports, informed consent documents, and other safety-related materials; Strong attention to detail

Nice to have

Experience in oncology and immunotherapy; Prior NDA/BLA submission experience; Oncology experience

Benefits

Annual performance incentive bonus; New hire equity; Ongoing performance-based equity; Medical, dental, and vision insurance; 401k match; Flexible time off; Paid holidays including year-end shutdown