Your role:
Leading development of evidence generation strategies of assigned projects, working within a cross-functional team.
Creating subsequent clinical development / evaluation plans.
Developing strong collaboration with KOLs and Investigators.
Participate in the interpretation & dissemination of evidence generated from clinical evaluation plans such as Clinical Study Reports and Clinical Evaluation Reports.
Supporting clinical evidence discussions with regulators, advisory boards, associations and societies.
You're the right fit if you have:
MD, PhD / MS Degree in Science, or Bachelors Degree with equivalent experience.
3-5 years of years experience in clinical research / development function, or related functional area.
Strong scientific background and deep expertise in the development of clinical evaluation methods.
Deep knowledge and understanding of all applicable standards / regulations in clinical evidence generation and dissemination, including GCP, FDA requirements, EU MDR, NMPA, etc, and a broad understanding of the clinical operations required to execute evidence generation strategies.
Proven ability to take independent action to initiate process improvement, when needed.
Anticipates changing priorities and demands and addresses them proactively.
Strong technology / therapeutic domain expertise with track record in successfully developing and executing clinical evidence plans.
Manage clinical development associates and specialists on day to day clinical tasks and / or Subject matter expertise in relevant domain (technology / therapeutic area).
Strong ability to critically assess clinical literature.
Excellent communication skills, including written communication (e.g., peer review publication) and oral presentation of scientific materials and research results. Ability to write original scientific documents such as clinical evaluation reports, clinical summaries, regulatory filings, investigator brochures, and internal reports and scientific publications.
