Sr. Manager, Medical Affairs Operations (Post Trial Access)

About this role

### Opportunity Details

Contract Sr. Manager, Medical Affairs Operations (Post Trial Access)

Remote, East Coast USA

# Senior Manager, Medical Affairs Operations

Company: KPS Life

Location: Remote (East Coast Time preferred) | ✈️ 1-2 team meetings/year on-site

## About the Role

We're seeking an experienced Senior Manager, Medical Affairs Operations to lead the execution of our clinical affairs programs, with a specialized focus on Post-Trial Access (PTA) initiatives. This is a pivotal role for a candidate who can architect and operationalize our transition from Phase 3 pivotal studies into post-trial access programs—providing investigational product to patients until regional approvals are secured.

You'll work independently managing multiple workstreams, coordinate cross-functionally with our CRO partners, and mentor junior team members as needed.

## What You'll Do

• **Design & Launch PTA Programs:** Develop and execute post-trial access strategies aligned with regional regulations, particularly in challenging markets—you'll be our expert in navigating complex regulatory landscapes
• **Operational Leadership:** Oversee clinical protocol review, TMF management, site qualification, vendor/CRO selection, and compliance with ICH/GCP standards
• ️ **Strategic Planning:** Lead study team meetings, manage budgets and timelines, develop recruitment strategies, and create training materials for sites and vendors
• **Cross-Functional Coordination:** Partner closely with Regulatory Affairs, supply chain, and site teams to manage drug transfers, shipments, and patient access logistics
• - ️ **Problem-Solving:** Identify program risks, implement mitigation strategies, and make data-driven decisions to keep initiatives on track
• ✅ **Compliance & Quality:** Ensure adherence to FDA regulations (GCPs, CFRs) and maintain rigorous document control

## About You

Required: ✋

• Bachelor's degree (preferably in a scientific discipl...