<div>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.   We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthetic psilocybin treatment, potentially a first in class treatment. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD) due to the pressing unmet need in this area. We are currently in phase 3 for TRD, have completed phase 2 studies for both post-traumatic stress disorder (PTSD) and anorexia nervosa and are planning a further late-stage study in PTSD. We envision a world where mental health means not just the absence of illness but the ability to thrive. - <a href="https://compasspathways.com/">Compass Pathways</a>.</div>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 London office). Reports to: Vice President, Clinical Safety and Pharmacovigilance. Roles and responsibilities (Include but are not limited to): <ul> <li>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</li> <li>Lead safety activities, benefit-risk strategies, and safety signal management for assigned studies and compounds</li> <li>Oversee aggregate safety review documents, safety labelling, and safety sections of clinical trial documents and regulatory filings, ensuring compliance with global regulations</li> <li>Oversee and manage vendors/CROs supporting Safety/PV functions</li> <li>Identify, evaluate, and manage safety signals through comprehensive data analysis author safety signal assessments and aggregate reports</li> <li>Prepare, coordinate, and submit safety reports (PSURs, DSURs, CIOMS, etc.) to regulatory authorities ensure ongoing compliance with local and international regulations</li> <li>Develop, maintain, and provide training on SOPs, PV processes, and procedures in accordance with Good Pharmacovigilance Practices (GVP)</li> <li>Collaborate with cross-functional teams (clinical operations, regulatory affairs, medical affairs) to address safety issues and develop effective risk minimization strategies</li> <li>Manage and develop PV scientists and mentor/supervise colleagues as positive change agents</li> <li>Represent Compass at Health Authority inspections, DMC meetings, and provide input to R&amp;D publication strategy</li> <li>Maintain thorough and accurate documentation of safety data, supporting timely and quality submissions and presentations</li> <li>Ensure all responsibilities are performed efficiently, accurately, and cost-effectively in line with current global regulatory and quality standards</li> <li>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</li> <li>Promote collegiality and teamwork among peers</li> </ul> Candidate Profile: <ul> <li>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</li> <li>Extensive industry experience in CNS, ideally psychiatry</li> <li>Demonstrated working knowledge of cGCP, ICH, and other relevant clinical development EU/US regulations and processes</li> <li>Experience/in-depth understanding of clinical trial/drug development from a regulatory perspective</li> <li>Excellent written and oral English communication and presentation skills and interpersonal skills to engage internal and external leaders proactively</li> <li>Proven ability to work effectively on a team in a collaborative environment</li> <li>Solid knowledge of Pharmacovigilance principles and international regulatory requirements regarding drug safety</li> </ul><div><h2>Benefits &amp; Compensation:</h2> For an overview of our benefits package and compensation information, please visit  <a href="https://compasspathways.com/join-us/">Working at Compass</a>.   <h2>Equal opportunities:  </h2> 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.  UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. <h2>Sponsorship:</h2> Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. <h2>Data Privacy:</h2> All data is confidential and protected by all legal and data privacy requirements, please see our recruitment <a href="https://compasspathways.com/recruitment-candidates-privacy-notice/" target="_blank">Privacy Notice</a> to learn more about how we process personal data.</div>

COMPASS Pathways

Senior Director, Clinical Safety and Pharmacovigilance

COMPASS Pathways

Similar Remote Jobs