Medical Director, Senior Medical Director – Drug Safety and Pharmacovigilance

🕒 May 13

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Neumora

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2021

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Biotechnology • Pharmaceuticals • Science

Neumora is redefining the field of neuroscience drug development by pioneering a new era of precision medicines for brain diseases. With a focus on developing targeted and effective therapies, Neumora aims to address the global brain disease crisis that affects over 1. 5 billion people. Their innovative approach revolves around the development of therapeutically relevant targets in Central Nervous System (CNS) diseases, emphasizing novel mechanisms of action and best-in-class pharmacology. The company's efforts are supported by their Precision Toolbox, which integrates translational, clinical, and computational tools to advance precision medicine approaches. Neumora is committed to transforming the future treatment of brain diseases by assembling a team of dedicated neuroscience drug developers and data scientists.

📋 Description

• 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).

🎯 Requirements

• 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 enable engaging and influencing 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

• 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 • Discretionary year-end bonus