Senior Director, Clinical Safety and Pharmacovigilance

Job Overview:

The Senior Director, Clinical Safety and Pharmacovigilance plays a key leadership role in driving our 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 NYC or London office).

Reports to: Vice President, Clinical Safety and Pharmacovigilance.

Roles and responsibilities
(Include but are not limited to):

• 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 comprehensive 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 (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop effective 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, data integrity, and accuracy 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 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 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