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Medical Director

Cambridge, MA

Posted: 06/18/2019 Employment Type: Contract Job Category: Clinical: Clinical Operations and Development Job Number: 2366

Our client, a leading company in cancer genomics based drug discovery, is looking to add a Medical Director with Hematological experience to its team on a Contract basis.

  • Drive and coordinate clinical development activities, including leading clinical study teams, monitoring overall study integrity and setting clinical strategy.
  • Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes opportunities for clinical and commercial success of the molecule
  • Serve as a primary medical point of contact with contracted CROs, investigators, ethics committees, IRBs, and opinion leaders/advisors
  • Participate in safety review meetings for cohort reviews of Phase 1 studies and coordinate where relevant with Data Monitoring Committee activities
  • Prepare clinical trial protocol drafts, study reports, amendments and informed consent forms, taking an active part in study design in internal discussion/meetings
  • Serve as a primary point of medical contact across all Company clinical trials and programs for patient safety and eligibility issues including review of safety reports (i.e. SAEs, important medical events)
  • Participate in implementation of pharmacovigilance activities including SOPs and procedures for preparation of SAE narratives and creation of cumulative safety databases
  • Coordinate medical writing for clinical protocols and study reports including preparation of clinical sections for FDA reports including IND submissions, EOP2 briefing documents, and annual reports
  • Contribute to publication strategy and preparation of abstracts, posters and manuscripts
  • Maintain expertise in GCP, clinical trial methodology, and relevant treatment landscapes through attendance at ASCO and/or other educational meetings/conferences

  • MD or equivalent training required; Hematological experience and/or training in Hematology highly preferred
  • Minimum 5 years of clinical trial management experience is required; previous industry experience as a study medical monitor or pharmacovigilance monitor or medical affairs role is preferred
  • Advanced knowledge of Good Clinical Practice (GCP) for conduct of clinical studies and associated FDA regulations for pharmacovigilance / safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
  • Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is required; medical journal publication experience is preferred
  • Excellent written and oral communication skills are required; experienced presentation skills and ability to prepare clinical data presentations in PowerPoint is preferred
  • Strong interpersonal skills and entrepreneurial can-do attitude is essential
  • Proficient  computer skills including  Word and Excel are required;  experience with statistical and pharmacovigilance databases or statistical software including SAS is highly preferred
  • Willingness and ability to travel up to 20% of time including domestic and international travel

Aaron Goldman
Clinical Recruitment Team Lead

Aaron is a spirited guy who likes to make things happen. He has been a Clinical Recruiter for the past five years, and says his greatest reward comes when a candidate accepts an offer and he hears the excitement in their voice - You know you have helped someone change their life!
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