Medical Director Global Metabolism/Neurology

Location
Menlo Park, CA, United States
Posted
Feb 03, 2021
Ref
1768376342
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
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