Contract Head of Clinical Operations
A great home-based opportunity has arisen for The Head of Clinical Operations to join a leading biopharmaceutical company. This is a contract role, were you will be given the chance to make a positive change towards medicine with the possibility of extension.
- Lead the Clinical Project Team (CPT), oversee the operational delivery of the Clinical Study Program(s) from initiation to final CSR and through to study closed and archived to agreed budget, time and quality and aligned with Key Performance Indicators (KPIs).
- Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with GCP.
- Provide expert clinical operational input into programme development and planning to ensure seamless delivery of studies through effective collaboration.
- Review any regulatory submissions. Lead the clinical operational team contribution along with Regulatory.
- Deliver differentiated and robust operational design options for the Board to review during key clinical programme investment discussion and decision.
- Plan and lead interactions, including issue escalation and resolution between Clinical Operations and other functions, such as Clinical Supply, Quality.
- Develop and manage clinical program risk and opportunity mitigation plans to ensure programme delivery with efficient resource utilization. Support as appropriate within the programme during issue and crisis management.
Skills and Requirements
- Essential Bachelor of Science/Arts in medical biological science, business or finance or related
- Minimum 10 years of experience in the pharmaceutical/biotech industry
- Extensive and proven experience in driving operational delivery to timelines, cost and quality
- Proven experience leading delivery through collaboration with internal organization and external providers
- Proven Global Project Management experience with expertise in program level resource and budget management
- Experience and strength in working and leading in matrix teams
- Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity
- Provide strong leadership and facilitation skills to link strategic direction to a clear operation plan
- Desired Strong coaching skills and an appreciation of how clinical development contributes to the broader business.
- Proficiency in Japanese.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Matthew Pike at 0207 440 0639 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.