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Associate Medical Director/Medical Director, Clinical Development

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Company: Cape Recruiting Group

Location: Cambridge, MA

Date Posted: January 6, 2014

Source: The Cape Recruiting Group

Associate Medical Director/Medical Director, Clinical Development
Are you a clinical development physician searching for your next role in Oncology? Our client is a small, growing nanopharmaceutical company located in Cambridge, MA. They are looking for a highly-motivated and results-oriented individual to join its clinical department team in the role of Associate Medical Director/Medical Director (depending on level of experience).
This full-time position will report directly to the Chief Medical Officer and includes responsibility for driving and coordinating the clinical development of the companys new clinical drug candidate and integrating the preclinical, clinical and competitive data to commercial success.
RESPONSIBILITIES:
  • Drive and coordinate the clinical development of drug candidate entering phase 1 clinical evaluations in the 2nd half of 2013.
  • Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes the clinical and commercial success of the nanopharmaceutical.
  • Primary medical point ...
Associate Medical Director/Medical Director, Clinical Development
Are you a clinical development physician searching for your next role in Oncology? Our client is a small, growing nanopharmaceutical company located in Cambridge, MA. They are looking for a highly-motivated and results-oriented individual to join its clinical department team in the role of Associate Medical Director/Medical Director (depending on level of experience).
This full-time position will report directly to the Chief Medical Officer and includes responsibility for driving and coordinating the clinical development of the companys new clinical drug candidate and integrating the preclinical, clinical and competitive data to commercial success.
RESPONSIBILITIES:
  • Drive and coordinate the clinical development of drug candidate entering phase 1 clinical evaluations in the 2nd half of 2013.
  • Take a major role in integrating pre-clinical, clinical, and competitive data to generate a development plan that maximizes the clinical and commercial success of the nanopharmaceutical.
  • Primary medical point of contact with contracted CROs, investigators, ethics committees, IRBs, and opinion leaders/advisors
  • Participation in safety review meetings for cohort reviews of Phase 1 studies as primary Sponsor representative and coordination with Data Monitoring Committee activities
  • Preparation of phase 2/3 clinical trial protocols, study reports, amendments and informed consent forms, taking active part in study design in internal discussion/meetings
  • Primary point of medical contact across allcompany clinical trials for patient safety and eligibility issues including review of safety reports (i.e. SAEs, important medical events)
  • Lead implementation of pharmacovigilance activities including SOPs and procedures for preparation of SAE narratives and creation of cumulative safety databases
  • Lead 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
QUALIFICATIONS INCLUDE:
  • MD or equivalent training required; oncology drug development experience and/or training in oncology 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 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
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