Medical Director Global Metabolism/Neurology

Location
Menlo Park, CA, United States
Posted
May 04, 2021
Ref
1768376342
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

The Medical Director will ensure the medical and scientific integrity of clinical trials conducted by Company in the therapeutic area of Metabolism/Neurology.

Essential Duties/Tasks

  • Act as clinical scientist and clinical subject matter expert for both Company team members and for external contacts related to the assigned therapeutic programs
  • Provide training and ongoing input to all members of the clinical team on medical and scientific issues related to the therapeutic field in question
  • Provide scientific oversight for Company operational staff, contract research organizations (CROs), and clinical trial sites in all areas related to the therapeutic programs
  • Design, develop and, implement clinical studies for the applicable drug candidate, from Phase I through Phase III
  • Develop and participate in the writing and review of protocols, investigator brochures, study reports and other clinical and regulatory documents
  • Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems and final reports
  • Acts to provide medical oversight and safety monitoring for ongoing clinical trials including participation in SAE reporting and serving on the safety committee
  • Play a key role in the analysis, interpretation and delivery of high quality clinical data
  • Interact with principal investigators and opinion leaders to facilitate clinical trials research
  • Participate in appropriate regulatory discussion and activities, including the filing of IND's, CTXs, NDA/MAAs, throughout the development cycle
  • Participate in clinical study report conceptualization, development and writing for global regulatory submissions
  • Work closely and collaboratively with other functions, e.g. clinical operations, safety, biometrics, regulatory, medical writing, medical affairs and commercial
  • Develop and give internal and external presentations as subject matter expert for the therapeutic area
  • Participate in the development and review of publications
  • Prepare and monitor budgets in collaboration with clinical operations and R&D finance
  • Participate in the management of human resources in a matrixed environment - recruitment, performance management, succession planning, talent management, etc.
  • Serve as liaison to the commercial team on medical issues


Preferred Education and Experience

  • MD, board certified (or eligible) preferably in Endocrinology, Gastroenterology or Neurology
  • Requires at least 5 years of relevant clinical development experience
  • Relevant basic and/or clinical research experience in academic settings is viewed favorably


Preferred Skills, Qualifications or Technical Proficiencies

  • Strong clinical and scientific knowledge
  • Excellent communicator with proven leadership skills and the ability to interact in a cross functional environment
  • Comfortable in a fast-paced and nimble small company environment and able to adjust workload based upon changing priorities


Position Location - Must be located in the North California/Bay Area. Out of state applications will only be considered if you have indicated that you are willing to relocate to the Northern California/Bay Area.