Director of Clinical Operations
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
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.
Key Skills
- Risk Management
- Negiotiation
- Operational management
- Smartsheets
- Strategic Planning
- Team Management
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Financial Planning
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more
