Medical Director

• Leading the direction, planning, execution of clinical trials and interpretation of clinical data
• Establishing scientific methods for design, implementation of clinical protocols, and ensuring trial subject safety
• Leading clinical trials, phases I - IV, for company products under development
• Building and managing the clinical research scientist team supporting clinical trials and overseeing CROs and other vendors
• Building reliable relationship with clinical investigators, discussing trial design, leading investigator’s meetings and advisory boards
• Monitoring safety and reporting adverse events
• Coordinating and developing information for reports submitted to the FDA and other health authorities and representing the Company at different forums
• Monitoring adherence to protocols and determining study completion
• Reviewing clinical data and leading/authoring reports and study related documents, such as IBs, study protocols, publications and regulatory filings including briefing documents, reports, and IND/BLA submissions
• Evaluating products for in/out licensing
• Participating in cross-functional teams, working in a highly matrixed team environment to advance preclinical programs to clinical evaluation
• Staying abreast on the clinical development and regulatory issues related to other competitive or relevant compounds in development and providing recommendations on changes needed to our strategy or clinical development plan as a result
• Provide medical review, assessment and interpretation of clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
• Adhere to both Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) aligned with the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

Medical Director

Associate Medical Director

Senior Medical Director, Late Development, Breast Oncology

Senior Medical Director, Clinical Development

Medical Director – Enablement, Education, and Outcomes

Associate Director, Clinical Development – Medical Director, MD Required