Leads the group in planning, execution, and interpretation of clinical trials/research.
Oversees and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports as well as publications based on the clinical trials/research.
Oversees development, implementation and maintenance of appropriate standard operating procedures, standard work and policies to ensure compliance of regulations, guidelines and standards for clinical studies.
Collaborates with Regulatory Affairs and R&D to strategize best effective approaches to clinical study designs and execution to support regulatory approvals.
Responsible for providing high quality studies, data, documents and such to support US and OUS regulatory submissions.
Collaborates with R&D, Program Management, Regulatory Affairs and Quality Affairs on new product development (NPD) products and processes.
Collaborators with R&D to support beta studies and obtaining clinical samples to support product development. Maintains a biorepository.
Participates in the design of post market studies and provides support, as requested.
Maintains an effective working relationship with external collaborators, including principal investigators, CROs and reference laboratories.
Monitors developments in the field in order to be able to assess competitive activity, market developments, and to identify opportunities to broaden service utilization.
Routinely interacts with and reports to executive-level management on progress of Clinical Affairs programs and studies.
Oversees management of the budget and planning for Clinical Affairs.
Education and/or Experience
Bachelor’s degree in Clinical Sciences, Health/Life Sciences, Molecular Biology, Biochemistry and/or equivalent with 5+ experience or a Master’s/Doctoral degree with 2+ years of experience
Minimum 2 years’ experience with In Vitro Diagnostic or Medical Device Clinical Trials
Knowledge and skills:
Successfully led and executed clinical studies that supported FDA clearance/approval of In Vitro Diagnostic (IVD) products and CE Marking, preferably in molecular diagnostics of infectious disease.
Experience leading teams
Working knowledge of FDA and IVDD and IVDR regulations.