The Invex Therapeutics Head of Clinical Operations (m/f/d) is accountable to lead the overall execution of clinical programmes.
They will report to the Chair and will provide leadership, project management and programme oversight for the timely, quality preparation and execution of the international clinical
development program (Phases I – III).
The position will be based in the United Kingdom.
• Accountable for overall management of clinical trials including study deliverables, milestones and data quality
• Management oversight of CROs and further relevant study vendors including coordination of evaluation, selection and monitoring to ensure successful clinical trial implementation and execution within established timelines, budget and quality expectations
• Proactive planning, driving and tracking trial progress, performance, timelines and financial metrics on an ongoing basis to management team
• Work collaboratively with cross functional internal and external teams including regulatory affairs, drug safety, medical and development functions
• Leading, managing and developing the clinical operations team to ensure all department goals and deliverables are met
• Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report
• Drive operational excellence, continuous improvement in process standards/tools and establish best practices in clinical trial management
• Degree in Life Sciences (preferably Medicine) with professional experience appropriate to the post in international clinical research within biotech/pharmaceutical industry, preferably in the field of neurology (headache, vision)
• Extensive knowledge of global clinical development processes, regulatory requirements and GCP
• Proven capabilities in clinical operations process improvements
• Experience in people management with proven ability to effectively lead, coach and manage scientific professionals toward a successful outcome
• Strong interpersonal, communication, negotiation and problem solving skills
• Essential to have a hands-on mentality
• Ability to organize, prioritize and work effectively in a fast-paced life sciences company environment and to motivate a team to do the same
What we offer
• Key leadership role and active participation in an inspiring biotech environment within the promising field of immuno oncology
• Innovative study designs with “thinking out of the box” approach
• Flat hierarchies and short decision-making paths combined with an open corporate and leadership culture
• Opportunity to actively shape the future of the company
To apply please email your CV/Resume and cover letter to: email@example.com