Head of Clinical Operations
Company: Edelway Switzerland AG
Location: Basel area
Closing Date: 29 Dec 16
Type: Full Time
Salary (£): Negotiable
Edelway is a pan-european Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Basel Area is currently looking for experienced Head of Clinical Operations.
Provide leadership to the Clinical Operations organization. In alignment with Global Clinical Operations, defining and driving organizational strategies and ensuring strategic operational planning, optimal trial allocation, and high quality and compliant execution of biosimilar clinical programs/trials within agreed clinical program timelines and budget.
- Ensure high quality clinical operational input into biosimilar clinical development plans, outsourcing strategies, and trial execution plans.
- Participate in overall program and trial operational prioritization including outsourcing strategy.
- Provide guidance to trial leaders in the ensure timely and efficient operational execution of biosimilar clinical trials.
- In collaboration with the Head, Global Clinical Operations, ensure efficient utilization of resources within Clinical Operations to meet the business needs including coordination of headcount requests and resource alignment.
- Establish culture of continuous process improvement and establish best practices in biosimilar clinical program and trial management.
- Develop partnership or collaboration with other divisions to realize synergies and drive efficiencies and quality standards in biosimilar trial execution.
- Develop expertise and ensure quality and compliance with GCP and Pharmacovigilance requirements.
- Provide oversight on quality and compliance in collaboration with Clinical Quality Assurance and ensure coordination of responses to audit issues.
- Lead Clinical Trial Teams in preparing for the Health Authority inspections and Internal System audits.
- Represent the Clinical Operations during these inspections and audits.
- Manage direct reports and provide guidance, mentoring, and assistance to all in setting workload priorities.
- Master’s/Bachelor’s Degree or equivalent plus 10 years minimum experience in pharmaceutical industry (specifically in Development and Clinical Operations).
- Excellent knowledge in all aspects of clinical drug development.
- Strong leadership, negotiation, conflict resolution and project management skills.
- Experience working in a global organization and in matrix environment.
- Experience with FDA inspections.
- Successful in people management and development.
- Strong cultural awareness.
- Excellent supervisory, organizational.
If this sounds like your next challenge please send us your CV at “email@example.com“ or contact us at +34 93 018 5722.