VP of Clinical Operations
A leading and innovative biopharmaceutical company is currently recruiting a VP of Clinical Operations to join their office in Switzerland. This organisation is renowned for its work on high-quality biosimilar medicine to help people live longer, healthier and more active lives. Based in Zurich, this is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
- Accountable for implementing clinical operations strategy for all clinical trials and for overseeing clinical operations activities with regards to quality, timelines, and budget.
- Ensuring GCP compliance of sponsored clinical trials.
- Establishing/updating processes and align activities to streamline the operational conduct of all clinical trials.
- As part of a multifunctional team, the VP of Clinical Operations is a key function in the identification and selection and will be responsible to oversee Contract Research Organisations (CROs) execution of clinical deliverables.
- Accountable for implementing clinical operations strategy for all the company's clinical trials and for overseeing clinical operations activities with regards to quality, timelines, and budget.
Skills and Requirements:
- Master of Sciences or equivalent. (Desirable) Ph.D. or equivalent.
- 10+ years in relevant functions in the Pharmaceutical Industry, or equivalent.
- Prior exposure to Biosimilar desirable, but not essential.
- Experience with successful oversight of vendors, including significant outsourced operations, and proven track record of ensuring quality deliverables or services in a cost-effective manner.
- Previous experience with Eastern European countries is desirable.
- Proven Leadership skills and demonstrated ability to interact collaboratively in a cross-functional environment required.
- Demonstrated experience leading and/or establishing a Clinical Operations group and/or function.
- Long-standing experience in all phases of clinical drug development, a thorough understanding of the overall drug development process as well as a strong operational background are required.
- Prior experience with the development of biosimilar drugs is desirable, but not essential.
- A proven track record of effective project and people management is required.
- Strong communication, interpersonal, organisational and collaboration skills are expected.
- Significant experience in/with the CRO business is required and to oversee CRO activities.
- Ensure GCP compliance in all the company's clinical trials.
- Oversee all aspects of clinical trial budgets, supporting contract negotiation and execution, as needed.
- Ensure Clinical Trials are executed according to company timelines.
- Assist with the development of clinical protocols to comply with WHO standards.
- Establish and harmonise processes and procedures across different clinical programs and across teams.
- Participate as a member of the company's project teams, ensuring clinical operational challenges and issues are proactively identified and clearly articulated.
- Supports Clinical QA activities, as appropriate.
- Participate in business development and strategic planning activities to ensure a productive and viable product portfolio.
- Assist in the development of the clinical strategy.
- Engage key stakeholders to streamline the conduct of clinical trials.
- Work with Clinical Quality to implement and update policies, Standard Operating Procedures (SOPs) and Work Instructions (WIs), as required.
- Up-to-date with the state-of-the art technology, trends, and requirements in clinical operations.
- Up-to-date with ICH-GCP requirements.
- Strong organisation and management skills are required to lead, participate and make a positive contribution to team meetings.
- Deep knowledge and understanding of Good Clinical Practice (GCP).
- Collaboration and interpersonal skills is expected to build team spirit, be tolerant and considerate, be an active and open communicator and share knowledge and experience with other team member.
- Proficient in use of a PC and common Microsoft packages such as Word, Visio, Excel, PowerPoint, MS Project.
- Fluent in English, both written and verbal.
- Willingness to travel internationally, as required.
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 Lewis Davis at +44 203 078-9569 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.