Senior Director, Clinical Safety & Pharmacovigilance

Join to apply for the Senior Director, Clinical Safety & Pharmacovigilance role at Compass Pathways

Location: Remote on the East Coast, United States or United Kingdom (or hybrid in our NYC or London office).

Reports to: Vice President, Clinical Safety and Pharmacovigilance.

Job Overview

The Senior Director, Clinical Safety and Pharmacovigilance plays a key leadership role in driving patient safety and shaping risk management strategies across global clinical development. This position offers the opportunity to champion pharmacovigilance excellence, proactively manage safety signals, and steer impactful medical monitoring in an innovative, science-led environment.

Roles and responsibilities

• Serve as drug safety SME for Compass clinical development programs and as primary Sponsors medical contact or medical monitor for assigned Phase 1-3 studies
• Lead safety activities, benefit-risk strategies, and safety signal management for assigned studies and compounds
• Oversee aggregate safety review documents, safety labeling, and safety sections of clinical trial documents and regulatory filings, ensuring compliance with global regulations
• Oversee and manage vendors/CROs supporting Safety/PV functions
• Identify, evaluate, and manage safety signals through data analysis; author safety signal assessments and aggregate reports
• Prepare, coordinate, and submit safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities and ensure ongoing compliance with local and international regulations
• Develop, maintain, and provide training on SOPs, PV processes, and procedures in accordance with Good Pharmacovigilance Practices (GVP)
• Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop risk minimization strategies
• Manage and develop PV scientists and mentor/supervise colleagues as positive change agents
• Represent Compass at Health Authority inspections, DMC meetings, and provide input to R&D publication strategy
• Maintain thorough and accurate documentation of safety data, supporting timely and quality submissions and presentations
• Ensure all responsibilities are performed efficiently, accurately, and cost-effectively in line with current global regulatory and quality standards
• Accountable for compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System, ensuring participant safety and data integrity throughout the trial process
• Promote collegiality and teamwork among peers

Candidate Profile

• MD/DO/MBBS required with considerable experience in the pharmaceutical industry, predominantly in the drug safety/medical monitoring function; track record of successful product launches
• Extensive industry experience in CNS, ideally psychiatry
• Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes
• Experience and in-depth understanding of clinical trial/drug development from a regulatory perspective
• Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively
• Proven ability to work effectively on a team in a collaborative environment
• Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety

Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work; any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.

Base salary per annum: $260,000 - $320,000 USD

Benefits & Compensation

For an overview of our benefits package and compensation information, please visit the Working at Compass page.

Equal opportunities & Reasonable accommodation

We are committed to building a workplace where everyone’s wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know.

Sponsorship: We cannot sponsor employment visas and can only accept applications if you have employment rights in the country you are applying to.

Data Privacy: All data is confidential and protected by legal and data privacy requirements. Please see our recruitment Privacy Notice to learn more about how we process personal data.

Job details

• Seniority level: Director
• Employment type: Full-time
• Job function: Research
• Industries: Biotechnology Research and Pharmaceutical Manufacturing