Senior Manager, Medical Affairs Operations (Fixed-Term Contract)

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