Medical Director, Clinical Safety

Compass Pathways; United Kingdom; Hybrid; GBP 100,000 - 150,000; Full time

Job summary

A leading biotechnology company is seeking a Medical Director, Clinical Safety to oversee medical monitoring for clinical studies. The role requires an MD or equivalent, ideally a psychiatrist with extensive CNS research experience. This position can be remote within the UK or hybrid in London. You will ensure compliance with regulations and collaborate on strategic clinical development decisions.

Qualifications

• Licensed to practice medicine in the US or UK.
• Fully qualified psychiatrist strongly preferred.
• Extensive CNS clinical research experience.

Responsibilities

• Oversee CRO medical monitoring activities in clinical studies.
• Ensure compliance with ethical and regulatory standards.
• Collaborate on strategic decisions related to clinical development.

Skills

Clinical research expertise

Leadership skills

Good communication

Knowledge of regulatory guidelines

Education

MD, MBBS or equivalent

Job description

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. - Compass Pathways.

Job Overview

The Medical Director, Clinical Safety will be responsible for the medical oversight of Compass-sponsored clinical studies, serve as a subject matter expert on the Clinical Sciences team, and provide expertise in the strategic development planning for pipeline compounds.

Location: Remote in the United Kingdom or hybrid in our Soho, London office.

Reports to: Vice President of Clinical Safety and Pharmacovigilance.

Roles and Responsibilities

• Oversee CRO medical monitoring activities in phase 2 and phase 3 studies
• Serve as the primary medical monitor for phase I studies
• Support DSMB meetings and data review as the Responsible Study Physician
• Provide general medical and psychiatry subject matter expertise for clinical study design, data interpretation, and relevant literature review
• Author and review clinical study documents and regulatory submissions, including protocols, monitoring and safety plans, DSMB charters, statistical analysis plans, study reports, investigator brochures, briefing books, annual safety updates, and external publications
• Contribute to the preparation and presentation of clinical trial data internally and at external conferences
• Offer strategic expertise in development planning for pipeline compounds based on experience
• Participate in scientific assessment and due diligence for potential business development opportunities as needed
• Lead workstreams and multidisciplinary project teams, supervise junior colleagues, and represent Clinical Sciences to development teams and senior leadership as situations require
• Ensure compliance with ethical and scientific standards, regulatory requirements, and the Compass Quality Management System to safeguard participant safety, data integrity, and accuracy throughout the trial
• Collaborate with senior leadership on strategic decisions related to clinical development, asset prioritization, and therapeutic direction
• Represent the company externally to clinical sites, key opinion leaders, patient advocacy groups, and scientific organizations
• Work with clinical operations to achieve project goals in terms of time, cost, and quality
• Ensure clinical research programs comply with industry standards and internal SOPs
• Build strong relationships with global investigators and thought leaders oversee advisory boards, investigator meetings, and conference participation

Candidate Profile

• MD, MBBS, or equivalent, and licensed to practice medicine in the US or UK
• Fully qualified psychiatrist strongly preferred
• Extensive experience conducting CNS clinical research in pharmaceutical drug development, as a medical monitor at a CRO, or as an investigator conducting industry-sponsored studies
• Strong knowledge of scientific principles, concepts, and communications
• Expertise in clinical research methods and statistical methods
• Good understanding of pharmaceutical drug development and familiarity with relevant ICH and regulatory guidances
• Demonstrated teamwork, leadership, and communication skills

Benefits & Compensation

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

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.

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.

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.

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