Medical Director/Senior Medical Director, Drug Safety and Pharmacovigilance
Neumora · United States · 1 mo ago
RemoteRemoteHealthcare$280k–$364k/yrPart-time
Responsibilities
- Provides pharmacovigilance and medical leadership of clinical programs to ensure timely delivery of clinical deliverables.
- Safeguards patient safety and oversees patient safety in clinical studies.
- Serves as the primary safety expert for assigned projects and acts as the initial point of contact internally and externally for safety inquiries.
- Analyzes and interprets data from internal and external sources and presents study updates, interim results, and final data to senior management as needed.
- 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.
- Participates in the creation of safety monitoring plans that integrate pre-clinical, early clinical findings, and pharmacovigilance approaches.
- Engages with external medical experts to address scientific and medical questions relevant to the program.
- Manages drug safety and pharmacovigilance vendors.
- Ensures proper reporting of Serious Adverse Events (SAEs).
- 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 the 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).
Qualifications
- 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 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
Benefits
2026 Company benefits include:
- 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 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
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Pay
The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $280,373 - $363,780