Associate Director of Clinical Development
Posted on Nov 11, 2018 by Millendo Therapeutics, Inc.
Millendo is seeking a medical expert (M.D. or D.O.) for assigned clinical trials. This role will provide input into the design and conduct of clinical trials, assessment and interpretation of clinical data, and investigator training.
Lead medical aspects of medical monitoring
Work closely with the CRO's to provide medical input into safety reports, including SAE narratives and analysis of similar events, Suspected Unexpected Serious Adverse Reaction (SUSAR) reports, Investigator Brochure (IB), Risk Management Plans, Integrated Summary of Safety, Clinical Study Reports, and preparation of labels
Further clinical development programs by assisting in the design and conduct of clinical trials, including: drafting of protocols and respective amendments, informed consent forms, data monitoring committee charters, and other supporting documents
Provide medical expertise for assigned clinical trials with the expectation to being readily available to advise on trial-related medical questions or problems during the conduct of the trial
Contribute to site and investigator training
Assist in medical reviews, assessment and interpretation of efficacy and safety data to ensure that the data are correct and presented with the appropriate medical interpretation
Responsible for medical monitor input into the development and implementation of standard operating procedures for all aspects of Adverse Event (AE) report handling, aggregate reporting and assuring compliance with global and local regulatory requirements
Responsible for implementing alignment across policies/procedures and ensuring that data generated are compliant with FDA and ICH guidelines and GCP.
M.D. or D.O., experience in endocrinology would be a plus
1-3 years of experience in drug development or clinical research, preferably in the pharmaceutical industry
U.S. and E.U. experience preferred
Fluent in oral and written English
Understanding of local and global drug safety regulations and processes and clinical trial oversight, including global GCPs
Excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders
Strong communication and presentation skills as well as an ability to communicate clearly and concisely in writing
This role reports into the Senior Medical Director and works closely with the Senior Director of Clinical Operations