Executive Director, Early Clinical Development - 22-150
Fully Remote
Description

The Executive Director, Early Clinical Development will lead the development of early assets. The successful candidate will join our team, working directly with Chief Medical Officer (CMO). This is an opportunity for a well-trained clinician with strong leadership skills who is driven by science and the desire to develop innovative therapies for cancer patients. The successful candidate will have a mastery of the drug development process in early phase clinical trials, protocol writing, study conduct, data review and reconciliation, the principles of translational medicine, and what it takes to lead teams successfully. This is a remote-based position.


Responsibilities:

  • Serve as Medical Monitor for Early Clinical Development assets, responsible for the safety monitoring of clinical trials, and as the medical expert for Phase I/II studies, managing the process from protocol development through individual study reports and integrated regulatory documentation; provide oversight and guidance to clinical team activities 
  • Monitor study progress ensuring proper study conduct and adherence to the protocol, lead data review, evaluation, and analyses with support from Data Management and Stats & Programming team
  • Address patient eligibility and treatment questions in cooperation with CRO or directly with study investigators
  • Review safety data for routine medical data review, trend review, and safety signals from ongoing trials
  • Assist as needed with the clinical development group in a variety of clinical deliverables, i.e., coding and data cleaning in collaboration with clinical operations and data management, collecting external data and competitive intelligence 
  • Author clinical sections in regulatory documents not limited to IND submission and annual updates, protocols, IB, briefing documents, and other study-related documents such as patient informed consent documents; author manuscripts, publications, or other documents intended for external audiences 
  • Serve as an internal resource for functions requiring clinical input on select assets, including primary point of contact for clinical trial teams at study sites for clinical issues, regulatory and safety, and other functions
  • Review potential in-licensing candidates and present recommendations to Senior Management groups
  • Contribute to the scientific, clinical, and commercial development of current and future product candidates; contribute to Strategic or Clinical Advisory Boards and support Medical Affairs and Business Development as needed
Requirements
  • MD (or equivalent) in Oncology, US fellowship, and board certification preferred
  • Training in basis or translational science training is preferred
  • A minimum of 10 years of experience with experience in small and large pharma may contain academic and clinical experience 
  • Experience with clinical trial design, conduct, and medical monitoring
  • Very familiar with IND process and submissions; experience and/or exposure with (s)NDA and MAA submissions and processes 
  • Knowledgeable and current in GCP guidelines 
  • Extensive knowledge of Hematology, Oncology and Immune-oncology clinical drug development, including FDA regulations, statistics, safety, etc.
  • Excellent written and verbal communication skills
  • Willing and able to travel as needed