Collaborate with cross-functional teams to develop and refine clinical trial strategies, ensuring alignment with scientific objectives and business goals.
Provide scientific leadership and guidance throughout the lifecycle of clinical trials, including protocol development, study design, and scientific review of study-related documents.
Contribute scientific insights to the selection of investigational sites, study endpoints, and the evaluation of scientific data, supporting the development of clinical trial protocols.
Identify potential scientific and operational risks within clinical trials and develop proactive strategies to mitigate these risks, ensuring the scientific integrity of the studies.
Stay abreast of relevant regulations, guidelines, and industry best practices, providing scientific input to ensure compliance with regulatory requirements in clinical trial conduct.
Collaborate with cross-functional teams to interpret scientific data, ensuring accurate and meaningful presentation of clinical trial results.
Coordinate early trial feasibility input.
Organize recurrent insights sharing within and from the clinical medical manager (CMM) network.
Identify early TA trends and plan solicited insights among CMMs.
Identify common trial challenges and suggest CMM intervention points.
Qualification & Experience
Should possess Bachelor’s/Advanced degree in a scientific discipline (e.g., MD, PhD, PharmD, MDS).
Should possess at least 2+ years of clinical and/or pharmaceutical industry experience.
A strong understanding of clinical research and drug development processes.
Demonstrated research experience (e.g. publications).
Proven experience in clinical operations, clinical trial management, or related roles within the pharmaceutical, biotechnology, or clinical research industry.
Strong understanding of regulatory requirements and guidelines governing clinical research.