Senior Director, Rems & Specialty Pharmacy Operations

Compass Pathways

New York, United States
On-site
Rems program operationalization
Specialty pharmacy distribution
Cross-functional integration
The Senior Director, REMS & Specialty Pharmacy Operations will lead the end-to-end operational design and execution of the REMS program and specialty distribution model supporting the launch of COMP360 in the US

Job Summary

  • The Senior Director, REMS & Specialty Pharmacy Operations will lead the end-to-end operational design and execution of the REMS program and specialty distribution model supporting the launch of COMP360 in the US.
  • This role will be responsible for translating regulatory REMS requirements and product distribution strategy into an integrated, scalable, compliant, and operationally efficient processes that enable treatment sites, patients, and internal teams to successfully navigate certification, enrolment, access, and treatment workflows.
  • This position will report to the VP, Patient Engagement and will work cross-functionally with Regulatory, Pharmacovigilance, Quality, Compliance, Medical Affairs, Trade & Distribution, Commercial, and Market Access teams.

Matching Summary

The Senior Director, REMS & Specialty Pharmacy Operations will lead the end-to-end operational design and execution of the REMS program and specialty distribution model supporting the launch of COMP360 in the US.

Skills & Requirements

Must-have

  • REMS program operationalization
  • specialty pharmacy distribution
  • cross-functional integration
  • vendor and technology management
  • site and field engagement
  • regulatory REMS requirements

Nice-to-have

  • thrives in ambiguity
  • build processes from the ground up
  • bridge regulatory requirements with execution

Key Requirements

  • Years of experience in REMS program management
  • Experience with specialty pharmacy operations
  • Experience in pharmaceutical launch
  • Experience with regulatory compliance

Work Rights

Not specified

Tailored Resume

Cover Letter