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Medical Director/Sr. Medical Director

Norwood, MA

Posted: 11/29/2018 Job Category: Clinical: Clinical Operations and Development Job Number: 2214

Our Client is looking to hire a Medical Director/Sr. Medical Director to lead and help take ownership of one or more progressing clinical trials while providing strategic direction, leadership and medical expertise to the clinical development team. This role provides the opportunity for the right candidate with superior protocol writing, medical monitoring and KOL interaction skills and experience to truly make an impact on the lives of patients and future success.

RESPONSIBILITIES INCLUDE:
  • Provide leadership and medical expertise to Company’ s clinical development programs including Phase 3 studies
  • Build effective relationships with site investigators and KOLs
  • Lead safety surveillance, risk management and risk communication activities including medical reporting and assessment of adverse events
  • Develop risk management profiles
  • Write protocols while working closely with CMO
  • Review and provide medical/safety input of PBRER, DSUR, clinical expert statement, etc.
  • Develop and direct overall drug safety operations processes to insure compliance with regulatory requirements U.S. and EMEA
  • Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support
  • Thorough understanding of medical coding (MEDRA)
  • Support regulatory submissions including NDA

REQUIREMENTS / QUALIFICATIONS:
  • Medical Degree with active U.S. medical license
  • 2+ years’ industry experience in a drug development organization (biotech, pharma, CRO) or 5 years academic experience running clinical trials
  • Thorough understanding of the benefit/risk management implications of drug development
  • Experience with Rheumatology/Allergy/Immunology strongly desired
  • Personal integrity and a commitment to patient and study participant safety
  • Understanding of cross-function drug development/clinical trial process
  • Excellent writing skills
  • Ability to thrive in a fast paced, entrepreneurial environment

Kelley Ross
Clinical Recruiter

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