Purpose of this position:
• To develop a strategic and consistent approach for the selection, implementation and overall management of Clinical Trial Operations and logistics, including but not limited to clinical study sites and external vendors (CROs) that supports our Phase 1 and Phase 2 clinical programs that run in both the EU and USA.
• To lead the Clinical Operation Team and work closely with associated matrix teams across Europe.
• BA/BS required; Advanced scientific degree is a plus.
• 10+ years of Clinical Operations with Phase 1 /2 Clinical Trial Management experience within the Pharmaceutical, Biotech or CRO industry.
• Direct report and matrix management experience is required. The candidate may currently be an experienced Director level candidate looking for their first Head role, or an existing VP level candidate.
• This will be a fully hand-on role with an essential ‘solution finding’ not ‘problem amplifying’ mind set
• Willingness to work in a fast-paced, creative, and scientific culture that requires a
• Working with the Chief Medical Officer and Clinical Department, external CROs and Translational Science teams to provide clinical operational support for multiple oncology based programs currently in multiple Phase 1 and Phase 2 multi-cohort clinical development across EU and US sites.
• Understand the Company vaccine based biological mechanism, clinical strategy, scientific interpretation of disease and target-based literature.
• Ensure that appropriate capabilities, infrastructure, systems, standards and processes are in place to support execution of Development activities.
• Oversee execution of all operational activities to ensure clinical study delivery.
• Lead vendor selection and portfolio management (including issue escalation) and oversight of all outsourced activities.
• Create and drive study and program level timelines.
• Develop and manage study and program level budget.
• Develop overall feasibility concept and patient enrolment plan.
• Responsible, Manage and further build a fit-for purpose scale Clinical Operations team.
• Oversee Data Management from the CRO team.
• Mentor direct reports.
• Allocate clinical operations and DM resources based on clinical trial needs.
• Support Head of Regulatory Affairs with regulatory submissions, IMP management, audits/inspections and resolution of findings
• Ensure regulatory compliance and Good Clinical Practice compliance
• Develop and manage Study Management Plan and all associated documents (i.e. vendor oversight plan)
• Ensure monitoring plan is developed and consistently executed.
• Ensure Clinical Operations team and external partner receive study specific training.
• Develops and owns clinical SOPs.
• Primary contact for legal and operation teams on contractual implementation and adherence for all clinical programs.
Management Supervision of staff:
• The candidate will have the ability to shape and grow the Clinical Operation team as demands increase