Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance

The Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance will manage the safety aspects of Neumora clinical studies, in collaboration with pharmacovigilance operations, clinical development, clinical operations, toxicology, and other clinical and pre-clinical functions, to provide medical insights and promote integration of drug safety strategies in Neumora’s development programs.

• →Provides pharmacovigilance and medical leadership of clinical programs to ensure timely delivery of clinical deliverables.
• →Ensures clinical programs support patient safety and provides oversight of patient safety in clinical studies.
• →Serves as the primary safety expert for assigned projects and as the first point of contact internally and externally for questions regarding patient safety.
• →Contributes to the analysis and interpretation of data generated internally or externally and presents study updates, interim results, and final headline data to senior management as required.
• →Provides medical input and contributes to the safety sections of regulatory documents such as CIOMS, DSUR, IND and NDA Dossiers, and contributes to responses to regulatory agencies regarding questions about complex safety issues.
• →Participates in the cross-functional development of safety monitoring plans that integrate pre-clinical, early clinical findings and pharmacovigilance approaches.
• →Identifies and engages with external medical experts to address scientific and medical questions relevant to the program.
• →Manages drug safety and pharmacovigilance vendors.
• →Ensures that Serious Adverse Events (SAEs) are properly reported.
• →Engages in signal detection and aggregate safety review and benefit-risk assessment.
• →Contributes to reference safety information and investigator brochure safety sections.
• →Interacts with health authorities, including Food and Drug Administration (FDA).
• →Creates Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).
• →Interacts and liaises with Data Monitoring Committees (DMCs).

• MD required; board certification in a medical specialty, such as internal medicine, preferred
• Active medical license desirable
• 5+ years of relevant experience as a Safety Physician in the biotech or pharmaceutical industry or equivalent with oversight of Phase 2 and 3 studies; Phase 1 experience also desirable
• New Drug Application (NDA) experience preferred
• Psychiatry or neurology drug development experience preferred
• Experience in leading safety aspects of clinical studies on cross-functional teams
• Ability to critically review, analyze and interpret key aspects of clinical study conduct, including research design, methods, outcome measures, is required
• Ability to work in a hybrid environment and with distributed teams; startup experience preferred
• Effective communication skills to enable engaging and influencing diverse stakeholders from a variety of professional backgrounds
• Ability to navigate complexity and make risk-based decisions
• Self-starter who can independently lead assigned projects