The Director, Clinical Affairs provides leadership regarding the scientific and medical strategy for clinical projects and has the accountability for designing clinical programs to meet defined registration and business objectives. Primary role for this position involves managing the global clinical study team in the successful execution of medical device clinical studies, primarily IVDs, to satisfy global regulatory agency requirements and provide data to drive adoption upon product launch. This position is also the clinical/medical liaison between internal teams and external parties such as SMFM, ACMG, APHL, Key Opinion Leaders, Advisory Boards, CROs, regulatory agencies.
- Manages clinical study and operational teams
- Provides multidisciplinary, scientific leadership across multifunctional project teams.
- Provides scientific, technological and medical knowledge and expertise for the clinical research aspects of the project and provides clinical expertise, with a strong working knowledge of regulatory affairs, to the development of the clinical strategy for projects.
- Serves as key clinical research representative for products in development at strategic meetings/advisory boards.
- Provides medical and scientific input to the core documents for the project (e.g., product strategy documents, target product profile (TPP), protocols, submission, etc.).
- Consults with internal/external stakeholders and internal/external key opinion leaders to validate the scientific and medical components of clinical strategies.
- Works closely with the clinical affairs team, and provides strategic direction to support timely and on budget development and execution of the clinical strategies.
- Serves as the medical or scientific representative with investigators and regulatory authorities.
- Develops and gains approval by Senior Management for study protocol outlines and study plans created by the clinical project team.
- Mentors and transfers knowledge across project teams.
- Participates and supports the clinical study team in site selection/evaluation including site training and to provide sufficient Medical/scientific knowledge for educating the study team and investigators and explain the scientific, epidemiologic background and justification of a study/project.
- Plays a primary role in identifying key opinion leader(s)/principle investigators for the program to ensure adequacy of the program’s scientific basis and obtain endorsement on the assumptions related to medical needs and clinical utility represented in the project development strategy.
- Provides medical and scientific interpretation of efficacy and safety data and to seek advice of other experts as required.
- Accountable for the clinical study reports including expert reports, integrated summaries, and other regulatory documents, etc.
- Plays a key role in the interactions with regulatory authorities (e.g., FDA, EMEA meetings). This includes developing key documents, participating in the preparation for meetings with the health authorities, and participating in the meetings and interactions with the health authorities. To serve as the main scientific/medical representative during these interactions, with support from other project team members as needed.
- Helps to identify additional opportunities within the broad R&D portfolio; propose indications and study design approaches for establishing proof of concept and help to identify and evaluate opportunities for in-licensing or mergers/acquisitions that would expand the platform portfolio.
- Reviews abstracts and manuscripts created by internal or external sources.