Neumora

• 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).

• Lead the end-to-end supplier management lifecycle and audit program, including process ownership, continuous improvement, and audit scheduling (supplier, clinical investigator, and internal audits); oversee Quality Agreement and Risk Management processes. • Establish, maintain, and continuously improve QMS procedures, workflows, metrics, and practices to strengthen compliance and operational effectiveness. • Oversee the internal audit program and ensure associated process improvements are established, executed, and monitored for effectiveness. • Manage all aspects of documentation and records retention for supplier and audit management, including the routing and approval of documents, archival, and period review. • Partner with Manufacturing, Quality Control, Validation, Regulatory Affairs, Supply Chain, Clinical Development, and Clinical Operations to ensure appropriate application of QMS requirements across operations. • Lead, support and participate in regulatory authority inspections. • Manage external contractors and, where applicable, lead, coach, and develop QMS personnel, including prioritization of work, performance oversight, and support for professional development. • Serve as business owner for Quality-owned systems (e.g., Veeva Vault QMS), driving continuous improvement and ensuring systems remain in a validated state. • Support internal audits, customer audits, and regulatory inspections by ensuring quality systems and associated records are inspection-ready at all times. • Strengthen the Quality culture by leading cross-functional Quality initiatives.

• Independently and strategically develop and lead the DS development team. Closely collaborate with DP development team. Build strong GMP manufacturing partnerships with the appropriate capabilities to support drug development and GMP manufacturing throughout the clinical phases of development and commercialization. • Develop the group structure and the on-boarding of key personnel to accentuate internal skills as well as close internal gaps in knowledge/talent while managing full-time personnel and contingent workers. • Develop and meet functional goals to established timelines. • Provide technical leadership and subject matter expertise throughout the various clinical phases of development, scale-up and commercialization of small molecule DS processes including DS manufacturing optimization. Collaborate with DP development team on DP process optimization and GMP manufacturing. Ensure DS and DP processes ultimately are efficient, robust and suitable for large-scale cGMP production, aligning process, validation, and supply approaches with overall program and portfolio objectives. • Define and maintain the technical framework for DS process lifecycle management (e.g., process validation and ongoing verification, and process performance optimization) and collaborate on DP process lifecycle management to support reliable clinical and commercial supply; act as lifecycle technical owner for DS processes, including process/impurity control strategy, continued process improvement and verification (CPV), and technical input into change controls across clinical and commercial stages. • Lead operational oversight of all DS technology transfer and process improvement activities and collaborate on all DP technology transfer and process improvement activities at CDMOs from early-stage clinical development through commercialization, including coordinating and reviewing technology transfers activities, reviewing and approving batch records, ensuring CDMO cGMP manufacturing readiness, overseeing production campaigns of key starting materials, DS, and DP in compliance with cGMP requirements, and providing timely resolution of technical, manufacturing performance and operational issues. • Oversee early-phase development personnel through the transition of processes from Discovery to CMC. Support early-stage (pre-clinical through Phase 2a) development activities by providing late-stage and commercial manufacturing perspectives to Neumora CMC and program teams and external partners. • Represent late-stage process strategy, validation and clinical/commercial manufacturing on internal Neumora cross-functional CMC and program teams, communicating risks, mitigation plans, and supply readiness for key program milestones. • Lead technical investigations, deviations and root cause analyses at CDMOs, including assessing product impact and implementing corrective and preventive actions; represent Neumora in technical discussions during regulatory inspections and partner diligence activities as needed. • Address challenges and conflict in real-time with a solution-oriented approach. • Collaborate with Manufacturing Operations, Quality, Regulatory Affairs, and CDMOs on the review/appropriateness of MBRs, process transfers, process verification, cleaning verification, process validation, and specification development, investigations, changes, and risk assessments to ensure compliance with cGMP and health authority expectations. • Oversee, prepare and/or review CMC sections of regulatory submissions (e.g., IND, CTA, NDA), including process description, control strategy, validation, and lifecycle management documentation. • Contribute to establishing best practices ways of working with CDMOs, including technical input into CDMO selection, technical due diligence, and continuous improvement of external collaborations. • Develop and maintain a phase appropriate QMS for PD and Manufacturing as appropriate. • Support CDMO audits and quality agreements within the scope of the role. • Serve as the Program Team Lead (core team and sub team as needed) lead on Neumora internal and external facing programs.