The Associate Director, Clinical Development Medical Director:
Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials. The role applies technical and clinical/medical skills to ensure the design of efficient and high-quality clinical trials, employing quantitative design principles, and clinical best practices to deliver both clinical and operational excellence.
Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines. The Associate Director, Clinical Development Medical Director is accountable for timely delivery of a quality protocol, clinical execution of clinical trials and supports appropriate interpretation and communication of clinical trial data.
Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review. May perform medical monitoring of one of more clinical trials.
Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
Performs medical monitoring on one or more clinical trials: Provides study-related medical information and assistance, e.g., medical questions from investigators, site personnel and non-study health care providers
safety findings, medical issues, and complex serious adverse events
audits or inspection medical responses
Contributes to final significant quality event medical assessments.
Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.
Reviews required safety text and endorses significant medical changes in the I