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

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.

Responsibilities

• Liaise with cross-functional teams including Regulatory Affairs, supply chain, and site teams to manage drug transfers, shipments, and patient access logistics.

• Lead study team meetings, manage budgets and timelines, develop recruitment strategies, and create training materials for sites and vendors.

• Oversee clinical protocol review, TMF management, site qualification, vendor/CRO selection, and compliance with ICH/GCP standards.

• Design and launch PTA programs aligned with regional regulations, particularly in challenging markets.

• Identify program risks, implement mitigation strategies, and make data-driven decisions to keep initiatives on track.

• Mentor junior team members as needed.

Requirements

• Bachelor's degree (preferably in a scientific discipline)

• 8+ years clinical operations experience managing clinical trials; at least 5 years in a supervisory/management role

• Extensive post-trial access expertise—you've successfully built and scaled PTA programs before

• Strong CRO/small biotech background

• Proficiency with Microsoft Office, electronic TMF systems, IRT, and EDC platforms

• Deep understanding of FDA regulatory requirements and GCP compliance

• Excellent communication and project management skills

• Ability to travel up to 10% (1-2 annual team meetings)

Preferred

• Rare disease and/or oncology experience

• Familiarity with international regulatory challenges for post-trial access

• Experience in endocrine rare disease