About this role

TFS HealthScience is a leading global mid size Contract Research Organization CRO that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service FSP solutions.

The Director of Clinical Operations is responsible for leading and coordinating operational activities supporting clinical stage development programs within CNS and rare disease indications, ensuring alignment across clinical supply, external manufacturing, quality coordination and vendor management in a regulated environment.

As part of our SRS FSP team, you will be dedicated to one sponsor, a global biotechnology company that is an industry leader within its therapeutic area.

This position is expected to require an approximate workload of 0.5 FTE.

Key Responsibilities

• Lead operational planning and execution supporting clinical development programs from Phase I to Phase III
• Coordinate cross functional activities across Clinical Development, CMC, Regulatory Affairs and Quality
• Oversee operational aspects of clinical manufacturing including tech transfer and scale up with external partners
• Manage relationships with CMOs and CDMOs for drug substance and drug product supply
• Ensure timely availability and release of clinical trial materials in compliance with applicable GxP requirements
• Support inspection readiness and audit preparation activities
• Coordinate clinical supply chain activities across development programs
• Support vendor selection, qualification and performance management
• Identify and mitigate operational and supply related risks

Qualifications

• MSc or PhD in Biotechnology, Biology, Pharmacy, Chemical Engineering or related Life Sciences discipline
• 8 to 12+ years of experience in Clinical Operations or CMC Operations within biotech or pharma
• Experience supporting clinical stage development programs within CNS and or rare diseases
• Experience working in regulated GxP environments
• Proven experience managing CMOs or CDMOs and external manufacturing partners

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full service global CRO, we build solution driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.