Medical Director, Senior Medical Director – Drug Safety and Pharmacovigilance

📋 Description

• Provides leadership in pharmacovigilance and medical oversight for clinical programs to ensure the timely completion of deliverables.

• Guarantees that clinical programs prioritize patient safety and oversees patient safety in clinical trials.

• Acts as the main safety authority for designated projects and serves as the initial contact, both internally and externally, for inquiries related to patient safety.

• Assists in analyzing and interpreting data generated by internal or external sources and communicates study updates, interim results, and final headline data to senior management as needed.

• Offers medical expertise and supports the safety sections of regulatory documents such as CIOMS, DSUR, IND, and NDA Dossiers, while also contributing to responses to regulatory agencies concerning complicated safety issues.

• Engages in the collaborative development of safety monitoring plans that incorporate pre-clinical findings, early clinical insights, and pharmacovigilance methodologies.

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

• Oversees drug safety and pharmacovigilance vendors.

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

• Participates in signal detection, aggregate safety evaluations, and benefit-risk assessments.

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

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

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

• Coordinates and collaborates 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.

• 5+ years of pertinent experience as a Safety Physician in the biotech or pharmaceutical sectors, or equivalent, with oversight of Phase 2 and 3 studies; Phase 1 experience is also a plus.

• New Drug Application (NDA) experience is preferred.

• Experience in psychiatry or neurology drug development is preferred.

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

• Required ability to critically review, analyze, and interpret key elements of clinical study execution, including research design, methodologies, and outcome measures.

• Capability to operate in a hybrid work environment and collaborate with distributed teams; startup experience is preferred.

• Strong communication skills to effectively engage and influence a diverse range of stakeholders from various professional backgrounds.

• Ability to navigate complexities and make informed, risk-based decisions.

• Self-motivated individual capable of independently managing 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 (equating to 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, and paid short-term and long-term disability.

• Discretionary year-end bonus.