Senior Medical Director

Summary

Join Neumora, a biopharmaceutical company revolutionizing brain disease treatment, as a Senior Medical Director. Oversee the medical and scientific aspects of clinical studies, ensuring high-quality conduct and patient safety. Collaborate with cross-functional teams, providing medical insights and integrating precision medicine strategies. Lead data review and analysis, author critical study documents, and contribute to regulatory submissions. Engage with Key Opinion Leaders, identify study sites, and implement clinical R&D policies. Support due diligence for potential in-licensing candidates and present recommendations to leadership. This role requires a strong medical background, extensive experience in clinical study oversight, and excellent communication skills.

Requirements

• MD required; Ph.D. and/or board certification in Psychiatry preferred
• 5+ years of relevant experience as a Medical Director in the biotech or pharmaceutical industry or equivalent with oversight of Phase 2 and 3 studies; Phase 1 experience also desirable
• Psychiatry drug development experience required
• Experience in leading medical and scientific 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
• Effective communication skills and demonstrated ability to engage and influence 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

Responsibilities

• Provides clinical development and medical leadership/oversight of clinical programs to ensure timely completion of clinical deliverables
• Ensures clinical programs support patient safety and provides oversight of patient safety in clinical studies
• As the primary medical expert for assigned studies, they are the first point of contact internally and externally for questions regarding the studies (e.g., eligibility, enrollment, safety and patient management). Monitors study progress to ensure proper study conduct and adherence to the protocol, leads data review, evaluation, and analyses with support from the cross-functional team. Takes a key role in the authoring of critical study documents (e.g., CSR, IB, protocol synopsis)
• 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 clinical development sections of regulatory documents such as IND, CIOMS, DSUR, Dossiers, and contributes to responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)
• Contributes to the cross-functional development of clinical development plans (CDPs) that integrate pre-clinical and early clinical findings and data sciences approaches, working to ensure cross-functional alignment on an ongoing basis throughout the phases of clinical development
• Collaborates with teams on the development of translational and precision phenotyping strategies and contributes to the design of scientifically rigorous clinical development studies and programs utilizing a data biopsy signature/precision phenotype approach. Ensures that teams appreciate the clinical relevance and applicability of the approaches considered
• Identifies and engages with external Key Opinion Leaders to address scientific and medical questions relevant to the program
• Helps identify global study sites and fosters relationships with study investigators
• Ensures that Serious Adverse Events are properly reported
• Implements clinical R&D policies, SOPs, and related directives
• As required, supports any needed due diligence of potential in-licensing drug candidates and/or technologies and presents recommendations to leadership

Preferred Qualifications

• Active medical license desirable
• Ability to work in a hybrid environment and with distributed teams; startup experience preferred

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• Company Equity (New Hire Awards, Annual Awards, ESPP)
• Accrued Vacation Days: 15 days per year
• Sick Days: 10 days per year
• Company Holidays: 13 days plus summer recharge week in July and winter shutdown in December
• Leave of Absence: Paid Medical Leave, Paid New Parent Bonding Leave, Paid Family Leave, paid short-term and long-term disability
• Discretionary year-end bonus