Medical Director, Clinical Development

Location
South San Francisco, CA
Posted
Jun 27, 2019
Ref
LN19-196
Required Education
Doctorate/PHD/MD
Position Type
Full time

Responsibilities

  • Act as a product and disease area expert and point of contact for other members of the team, working cross functionally with all the disciplines engaged in drug development activities, such as pre-clinical, CMC, QA,, regulatory, medical affairs, biostatistics/data management, pharmacovigilance, medical writing, and clinical operations.
  • Design and execute clinical trials
  • Support writing clinical trial protocols
  • Serve as a Medical Monitor for clinical trials, which could include assistance with site identification and communication, attendance at investigator meetings, development and participation in advisory boards, and data review
  • Assist with development of EDC, data analysis and presentation internally and externally
  • Contribute to drafting and reviewing clinical documents, abstracts, presentations, manuscripts, and regulatory submissions, such as investigator brochures, clinical study reports, protocols, IND’s, BLA’s, MAA’s and informed consent forms.
  • Cultivate relationships with key opinion leaders to represent the interests of the company
  • Work closely with Regulatory affairs in communications with health authorities, briefing books, and regulatory pathway submissions

Requirements

  • Excellent communication skills (interpersonal, written and verbal)
  • Must be well organized, polished, proactive, detail-oriented, mature and have a professional demeanor
  • Ability to multi-task and work efficiently in an environment with changing priorities
  • Demonstrate independence
  • Act with the highest integrity
  • Experience in a start-up environment
  • Travel time is 15-20% to investigative and CRO sites, regulatory agencies, and hematology meetings

Education and Training

  • Medical Degree required
  • At least 5 years of industry or academic experience; at least 3 years of experience with clinical trial design and execution
  • Experience in rare disease, especially benign hematology and hemophilia is preferred
  • Specialty training in hematology a plus