The Project Manager, Toxicology will be responsible for ensuring the efficient and timely delivery of Toxicology contributions to drug development programmes at COMPASS. The role will involve extensive interaction between COMPASS team members, CROs and our external collaborators.
COMPASS Pathways plc is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support.
COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com.
Reports to: The Director, Toxicology.
Location: United Kingdom (with partial office attendance).
Roles and responsibilities
Main responsibilities include (but are not limited to):
- Support management of outsourced toxicology study activities, including contracting and logistics with CROs
- Project management activities (e.g., critical path planning, budgets) to enable internal team to monitor study progress and ensure timely delivery of milestones (e.g., reports) to support regulatory submission(s)
- Ensuring communication between Toxicology team members to modify plans, deliverables etc according to latest regulatory knowledge and strategy
- Communication to Director, Toxicology about risks, issues and possible mitigation (planned and unforeseen)
- Point of contact for CROs and other external partners
- Oversight on final report, SEND and/or eCTD deliverables from vendors, and their suitability for regulatory submission(s)
- Understand the importance of document management (including archiving) for pivotal/non-pivotal Toxicology studies
- Degree in an appropriate life sciences discipline, with postgraduate Toxicology experience preferred, however, other applicants with suitable experience from pharmaceutical industry or biotech sector will be considered
- Experience of collaborating with CROs on preclinical scientific studies
- Proven track record of delivering project milestones (whilst leading cross functional collaboration) under time pressure
- Good relationship management skills, ideally with experience of remote management of multiple stakeholders
- Understanding regulatory requirements for non-clinical contributions
- Excellent written and oral communication skills
- Strong work ethic, transparency, and accountability
- Aligned to our company values of Compassion, Boldness, Rigour, and Inclusivity
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.