Director of Clinical Development

Employer
Glympse Bio
Location
Cambridge, Massachusetts (US)
Posted
Jan 07, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

Overview

Glympse Bio is looking for an experienced and highly motivated Director to contribute towards the development of activity-based sensors in nonalcoholic steatohepatitis (NASH), liver fibrosis, and liver cancer. This role will be responsible for planning and managing the conduct of both single-center first-in-human (FIH) and multi-center efficacy trials for combination products. Our noninvasive sensors are designed to provide physicians with accurate and predictive clinical data to transform the management and care of patients. This position provides the opportunity to lead the clinical development of cutting-edge combination products.

Responsibilities

Your responsibilities will include the following:

  • Develop clinical evidence strategy, create clinical development plans, and conceptualize and author clinical protocols
  • Assist in preparation and review of clinical trial documentation
  • Perform clinical research site activities, for monitoring, training, and/or relationship management
  • Participating in meetings with regulatory authorities including FDA to discuss clinical issues/questions
  • Provide support in preparation for scientific meetings (advisory boards, consultant meetings, investigator meetings), regulatory submissions, and labelling documents
  • Manage clinical trial budget, including participating in contract negotiations with CROs, clinical sites, and vendors
  • Facilitate communication of relevant scientific, clinical, or other findings to both internal and external stakeholders
  • Collaborate with KOLs/SMEs to gain feedback needed to design effective trials
  • Ensure trial adherence to company, local, federal, and international regulations

Qualifications

  • Advanced degree (PharmD, PhD, MD) in a life science or health science related field is preferred
  • 6+ years of experience in the medical device, biotech, or pharmaceutical industry
  • Experience designing trials for diagnostic products (ex: IVD, imaging agents) or companion diagnostics
  • Must have experience with strategic clinical trial design, planning, and budgeting
  • Demonstrated track record of managing both single and multi-center clinical trials conforming to current FDA, GCP, and ICH guidelines (combination product clinical trial experience a plus)
  • Experience in management of CROs, vendors, and consultants
  • Experience interacting with regulatory authorities in Europe and Asia
  • Familiarity with CLIA is helpful but not required
  • Excellent oral and written communication skills
  • Willingness to travel at least 20% of the time