Senior Medical Director, Pharmacovigilance and Patient Safety

Job Description

SENIOR MEDICAL DIRECTOR, PHARMACOVIGILANCE AND PATIENT SAFETY Day One Biopharmaceuticals is an emerging, mission-driven, drug development company intentionally designed to identify, clinically evaluate, and successfully commercialize novel treatments for pediatric oncology patients, and ultimately to expand those benefits to patients of all ages. For more information, please visit our website at . POSITION SUMMARY: We are seeking a hands-on, Senior Medical Director, Pharmacovigilance and Patient Safety (PPS) to lead Medical Safety activities for assigned drug projects and products, provide drug safety expertise and guidance to Clinical Development and cross-functional Clinical Project Teams, and drive proactive implementation of risk management initiatives in accordance with global regulatory requirements. This position will involve continuous, efficient monitoring of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development and post-market use, and oversight of communication of safety topics across all regulatory safety documents including regulatory authority periodic reports. Candidates should have a depth and breadth of drug development experience that is conducive to independent leadership of cross-functional activities on behalf of PPS, oversight of junior team members, and keen sense of prioritization and escalations based on team and company priorities. This role will be seen as a leader within the function. Solid attention to detail, sense of ownership, and ability to engage proactively with cross-functional colleagues are key characteristics for the ideal candidate. This position reports to the VP, Pharmacovigilance and Patient Safety and has the potential to be fully remote. Travel of 10%-15% will be typically required for in-person meetings and conferences. ESSENTIAL DUTIES AND RESPONSIBILITIES: Perform with strong commitment to Core values of Urgency, Ingenuity, Integrity, Compassion, and Excellence; especially when patients are involved Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources in order to predict/establish the safety profile of compounds in clinical development Escalates key safety topics and issues to leadership with the appropriate urgency and in accordance with DOB expectations, processes and procedures Supports and provides oversight for medical review of case narratives for medical content, accuracy, and signal detection Interprets aggregate safety data for periodic reports and evaluating for potential new signals Leads signal detection, signal evaluation, data analysis, and benefit-risk evaluation for assigned compounds, including oversight of contractor Safety Physicians as applicable Proactively leads implementation of risk management and mitigation activities, including medical and safety leadership for Risk Management Plans Writes individual case assessments and evaluates aggregate safety data for periodic reports Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals Proactively offers medical judgment on complex safety issues Presents safety data to Data Monitoring Committees or assigned products and internal Safety Assessment Committees Provides vendor oversight for assigned products where applicable (e.g., CROs contracted for safety reporting) Participates in cross-functional project teams including Clinical Trial Study Teams; communicates across organizational levels and functions – proactively providing PV subject matter expertise Contributes to the maintenance of the pharmacovigilance system and processes including partnership with Safety Analytics on Rx Logix tool Participates in SOP updates, audits, and inspection readiness Writes/updates core safety information for assigned projects in collaboration with Safety Operations Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects including protocols and periodic reports Supports preparation of regulatory authority and local/regional ethics board correspondence Supports preparation for external meetings with Health Authorities Guides and/or trains external personnel/parties involved in Company's clinical studies where applicable to Medical Safety Collaborates effectively in cross-functional and cross-cultural project teams and works with external providers including proactive engagement with other colleagues Maintains clinical and technical expertise in the therapeutic areas, i.e., through review of scientific journals, attendance at scientific and key technical meetings, etc. Participates in selection and bidding activities for vendors and contractors Ensures that safety science practices comply with Good Vigilance/ Pharmacovigilance Practices as well as internal safety processes, and maintains up-to-date knowledge of regional regulatory guidance documents Although strong foundation in general pharmacovigilance is expected, must be willing to participate in workshops and trainings to build skills and knowledge related drug development in pediatric and rare disease Managerial responsibilities as necessary QUALIFICATIONS Medical Degree (e.g., MD, MBBS, DO) with experience in a clinical setting required Training in epidemiology, pharmacology or MPH a plus 10+ years' experience as a Medical Safety Physician or similar experience with safety oversight activities related to clinical trials in academia or industry; Oncology therapeutic area 6+ years' experience in industry; small biotech experience Experience as a leader, mentor or people manager Comprehensive knowledge of clinical research and global regulatory requirements, and practices governing expedited and periodic safety reporting, signal, safety evaluation, and risk management activities, including regulations governing pharmacovigilance Strong skills in the management and communication of safety information originating from both clinical development and post-marketing sources Working knowledge of industry standard pharmacovigilance databases, particularly PVCM Strong leadership skills and ability to communicate with individuals at all levels on a proactive basis Excellent oral and written communication skills Excellent analytical skills, detail-oriented, and ability to work independently Ability to exercise creativity and judgment in a fast-paced environment #J-18808-Ljbffr