Clinical Supply Manager (Contract)
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, and has offices in New York City and San Francisco in the US. We focus on developing innovations that can improve 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 treatment, in which our proprietary formulation of synthetic psilocybin (which has received breakthrough therapy designation from the FDA) is administered with psychological support. We are currently in phase 3 study for treatment-resistant depression (TRD), and phase 2 for both post-traumatic stress disorder and anorexia nervosa. Our vision is a world of mental wellbeing - Compass Pathways.
Job overview:
The Senior Manager, CCI will lead a range of strategic and operational projects, working closely with, and leveraging the expertise of, other leaders within the Clinical Care Innovation function, as well as a range of other internal and external stakeholders, to (i) improve the quality and efficiency of our therapist training programme and (ii) support the adaptation and optimisation of this programme upon potential regulatory approval of our first investigational therapy/product.
Duration: 9-month contract.
Location: Home-based in the United Kingdom or hybrid in our Soho, London (UK) office.
Reports to: Senior Manager, Clinical Supply
Roles and responsibilities
Responsibilities include (but are not limited to):
- Ensure processes and systems are in place to effectively manage the Manufacturing & Supply Chain of Clinical Trial Materials;
- Oversee delivery of bulk Drug Product to Distribution partner on-time and ensure packaging, labelling, release and shipping to depots and clinical study sites on-time to meet required timelines for patient dosing
- Collaborate with regulatory partners and CROs to ensure approvals are in place to meet shipping deadlines
- Manage Drug Product shelf life and resupply as necessary to ensure continuity of supply to clinical study sites
- Contribute to revisions of IMPD as needed
- Manage and set-up collaborations with the world-wide partners selected for the clinical studies, in line with local requirements
- Build and maintain robust relationships with our key Manufacturing and Packaging partners
- Project Management activities (i.e. critical path planning, resources, budgets)
- Identify Risks, implement mitigation & controls, monitor & report status
Candidate Profile:
- Bachelor’s Degree in a science, operations management or other relevant subject
- Experience;
- Clinical Trial Supply experience (Labelling, Packaging, Warehouse and Distribution)
- Project Management
- Relationship Manager Management
- Stakeholder Managemen
- Specific skills;
- Working Knowledge of GCP & GDP
- Project Planning & Risk Management
- Ability to react to changing priorities
- Excellent interpersonal skills
Benefits & Compensation:
For an overview of our benefits package and compensation information, please visit "Working at Compass".
Equal opportunities:
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:
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