Senior Manager, Medical Affairs Operations (Fixed-Term Contract)
COMPASS Pathways
Operations
New York, NY, USA
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:
Compass Pathways’ organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining Compass Pathways now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.
You will support the VP in evaluating, tracking, and closing out IISs in close alignment with the IIS team. Based on an excellent understanding of the legal and regulatory requirements, the position will ensure that policies reflect the highest levels of ethics and compliance, that review of applications is based solely on scientific merit and alignment with prespecified scope, decisions are communicated in a timely manner, and that subsequent contracting and milestones are accomplished seamlessly.
Location: Hybrid in our New York City office or remote in the East Coast.
Reports to: VP, Pharmacovigilance and Clinical Safety.
Duration: 6-month contract.
Roles and responsibilities
(Include but are not limited to):
- Proactively share project status, issue escalation, and resolution; schedule meetings to facilitate cross-functional team discussions, decisions, issue resolution towards achieving project goals
- Must be able to work in undefined, cross functional teams and determine goals, identify challenges and work to completion of project or program
- Additional leadership to the broader team by having a positive, solutions-focused, innovative and collaborative mindset
- Ensure compliant processes consistent with medical and promotional review guidelines, industry regulations, and internal SOPs
- Support generation of reports, dashboards, and data insights to drive operational decision making
- Act as the liaison between Investigator Initiated study (IIS) sites and internal cross functional teams
- Facilitate IIS meetings with investigators as needed. Facilitate review of potential compliance related issues with the IIS leads for each function (Controlled drug licensing, issues related to contract and regulatory requirements, Controlled drug licensing issues including obtaining copies of controlled drug licenses/DEA licenses from the IIS PIs (if expired, obtain renewed license etc; ), follow up on IB submissions and approvals, oversight for return of unused drug for destruction as per CTA, etc)
- Ensure that the Pharmacovigilance department and IIS sites are updated with monthly Safety Reports/inquiries from sites
- Documentation of study communication for inspection and audit readiness
- Provide support to IIS activities as needed
Candidate Profile:
- Bachelor’s Degree required or PharmD/PhD equivalent experience, advanced degree preferred
- 7+ years of pharmaceutical/biotherapeutics industry experience
- Experience in drug safety, pharmacovigilance, quality assurance and compliance requirements are desirable
- 3+ years of Medical Affairs Leadership experience
- Experience in biomedical research, study feasibility
- Proven ability to influence and work successfully in a complex, global, matrix organization
- Resourceful with the ability to effectively manage multiple workstreams and projects
- High degree of analytical ability and conflict-resolution skills
- Ability to initiate and lead large, cross-function projects and see it through to completion
- Excellent communication and organizational skills
- Thrives in a flexible, dynamic environment
【For NYC】Compensation Description (annually):
Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
Base pay is one part of the Total Package that is provided to compensate and recognise employees for their work and any role at Compass, regardless of the location, is eligible for additional discretionary bonuses and equity.
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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