The Director, Clinical Development Scientist:
Is accountable for the scientific integrity of the study and the well-being of the patients enrolled in one or more clinical trials. The role applies technical and clinical 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 Clinical Development Scientist is accountable for timely delivery of a quality protocol, clinical execution of one or more large and / or complex 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 issues through timely, diligent clinical data, safety and protocol deviation review
Will also be the primary contact with external investigators & the internal study team for questions relating to clinical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
May also provide matrix management support of one or more IM clinicians on one or more clinical studies or across a clinical program
Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. Provides clinical input to support development of the protocol design document (PDD).
Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/supports the Global Development Lead in governance review and approval process.
Leads