Stellenbeschreibung
Interim VP Clinical Operations - Freelance
Search conducted on behalf of one of our clients, an international biotech company.
Project Details:
- Start: asap, 0.8 - 1 FTE
- Duration: 6 - 9 Months
- Full remote
Objective
Build the complete Clinical Operations function from the ground up for a biotech company with no existing clinical infrastructure.
Key Responsibilities
- Establish the full Clinical Operations framework: governance, SOPs, processes, compliance, and documentation.
- Set up budgets, vendor strategy, quality systems, and inspection readiness.
- Build and oversee processes for Investigator‑Initiated Studies in close collaboration with Medical Affairs.
- Ensure regulatory compliance (FDA/EMA), define all required documentation, and partner with Legal on contracts and risk management.
- Provide both strategic leadership and hands‑on operational execution in an international environment.
Profile Requirements
- VP‑level Clinical Operations leader with extensive Big Pharma experience (mandatory; US or Switzerland strongly preferred).
- Proven track record of building or transforming Clinical Operations organizations.
- Strong expertise in Oncology, IIS processes, Medical Affairs interfaces, Regulatory Affairs, and Compliance.
- Deep understanding of global clinical development standards, documentation requirements, and governance.
- Senior, confident leader capable of establishing structure and processes in a greenfield setting.
Desired Skills and Experience
- Investigator‑Initiated Studies
- IIS
- Medical Affairs Collaboration
- Leadership
- Clinical Governance
- SOP Development
- Quality & Compliance
- Inspection Readiness
- VP Clinical Operation
SThree_Germany is acting as an Employment Business in relation to this vacancy.
Benefits:
- Salary: 100 EUR (Min)
- Remote Model: Remote
- Country Code: de
