Medical Director, Senior Medical Director – Drug Safety and Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Provides leadership in pharmacovigilance and medical oversight for clinical programs to ensure prompt delivery of clinical outcomes.

• Ensures that clinical programs prioritize patient safety and supervises patient safety in clinical trials.

• Acts as the principal safety authority for designated projects and serves as the primary contact internally and externally for inquiries related to patient safety.

• Contributes to the evaluation and interpretation of data generated internally or externally and presents updates on studies, interim results, and final headline data to senior management as necessary.

• Offers medical insights and helps draft the safety sections of regulatory documents such as CIOMS, DSUR, IND, and NDA Dossiers, while also contributing to responses to regulatory bodies concerning complex safety inquiries.

• Involves in the multidisciplinary development of safety monitoring plans that encompass pre-clinical, early clinical findings, and pharmacovigilance methodologies.

• Identifies and collaborates with external medical experts to address scientific and medical inquiries pertinent to the program.

• Oversees drug safety and pharmacovigilance vendors.

• Ensures accurate reporting of Serious Adverse Events (SAEs).

• Engages in signal detection and comprehensive safety reviews, including benefit-risk assessments.

• Contributes to reference safety information and the safety sections of the investigator brochure.

• Interacts with health authorities, including the Food and Drug Administration (FDA).

• Develops Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS).

• Collaborates and communicates with Data Monitoring Committees (DMCs).

⛳️ Requirements

• MD required; board certification in a medical specialty, such as internal medicine, is preferred.

• An active medical license is desirable.

• Over 5 years of relevant experience as a Safety Physician in the biotech or pharmaceutical sector, or equivalent, with oversight of Phase 2 and 3 studies; Phase 1 experience is also desirable.

• Experience with New Drug Applications (NDA) is preferred.

• Background in psychiatry or neurology drug development is preferred.

• Proven experience in leading safety components of clinical studies within cross-functional teams.

• Ability to critically assess, analyze, and interpret key elements of clinical study execution, including research design, methods, and outcome measures, is essential.

• Capacity to work in a hybrid environment and with distributed teams; experience in startups is preferred.

• Strong communication skills to engage and influence diverse stakeholders from various professional backgrounds.

• Ability to navigate complexity and make decisions based on risk assessment.

• A self-motivated individual who can independently manage assigned projects.

🏝️ 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).

• Annual paid time off:

• Accrued Vacation Days: 15 days per year.

• Sick Days: 10 days per year.

• Company Holidays: 13 days plus a summer recharge week in July and a 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.