Senior Director, Clinical Safety and Pharmacovigilance

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

Company introduction
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. The Company is headquartered in London, UK, with offices in New York City in the US. We focus on developing novel treatments that have the potential to improve the lives of those who are suffering with mental health conditions and who are not helped by current treatments.

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.

Location: Remote in the United Kingdom (or hybrid in our London office).

Reports to: Vice President, Clinical Safety and Pharmacovigilance.

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 labelling, 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; 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 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
• 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 launch
• Extensive industry experience in CNS, ideally psychiatry
• Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes
• Experience in-depth understanding of clinical trial/drug development from a regulatory perspective
• Excellent written and oral English communication and presentation skills; strong 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

Benefits & Compensation

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

Equal opportunities

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

Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying.

Data Privacy

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

Note: This listing includes a company overview and role details; other job listings found in the original content have been omitted to maintain focus on the current role.