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Senior Medical Director

Evanston, IL

Posted: 05/05/2022 Employment Type: Direct Hire Job Category: Clinical: Clinical Operations and Development Job Number: 3070

Job Description

Our client is looking to add a Senior Medical Director to their team on a permanent basis. The Senior Medical Director is responsible for medical and scientific leadership of clinical development activities for pipeline projects, in full compliance with regulatory guidelines.   This role collaborates with internal research and development teams and external advisors/consultants to advance the company’ s research and development programs.

  • Provides therapeutic area expertise to inform company strategies, clinical development plans, and clinical studies.
  • Makes significant contributions to medical, scientific, and operational design of clinical development programs. 
  • Authors, reviews, and updates clinical protocols and development plans in collaboration with colleagues to ensure that the clinical goals for the company’ s program are met.
  • Leverages external consultants to expertly advance the company’ s development programs, including subject matter experts/key opinion leaders (KOLs) and medical staff at Contract Research Organizations (CROs)where applicable.
  • Identifies risks and risk mitigation strategies for clinical development programs and clinical studies.
  • Medically responsible for clinical development program execution, including subject safety in clinical studies and reporting of clinical safety information in regulatory documents and publications.
  • Partners with clinical investigators participating in client company’ s clinical studies to develop productive clinical study relationships with the company.
  • Collaborates with clinical development colleagues assigned to specific clinical studies including operational feasibility, site selection, case report form (CRF) design, study document preparation, study initiation, data collection, statistical analysis plans, data analysis, reporting, and presentations.
  • Collaborates with Safety Reporting disciplines to ensure timely and accurate adverse event reporting and follow-up.
  • Collaborates with Regulatory Affairs to prepare for the company’ s submissions, presentations, responses and guidance to the FDA or country specific regulatory authorities.
  • Collaborates with colleagues to provide scientific, medical, and therapeutic area expertise for the development of training materials, investor relations/business development materials, opinion leader relationships, and other company communication materials.
  • Identifies and responds to new and emerging medical and scientific needs as company’ s needs evolve.

Requirements / Qualifications:
  • Medical Degree (MD)
  • At least 10-15 years of clinical development experience in the pharmaceutical, biotechnology or CRO industries with:
  • Specific experience managing clinical studies in CNS/neuroscience, particularly in areas of interest for the company
  • Experience in chronic pain preferred
  • Experience working on clinical studies that led to the filing and FDA interactions for at least one NDA
  • Experience with the US FDA and EMEA, including pre-NDA, NDA and advisory committee interactions preferred
  • Substantial experience networking within the CNS-related disease community preferred
  • Expertise in the areas of clinical development, clinical operations, and strategic planning, specifically planning and management of clinical studies
  • Demonstrated knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulations governing clinical research
  • Must have extensive experience managing CROs, central laboratories, and other clinical study vendors
  • Must have a working knowledge of data management, data review and analysis, and drug safety and pharmacovigilance
  • Excellent communication/interaction skills and experience in a dynamic and growing organization
  • Ability to travel to investigator sites, investigator meetings, and scientific/medical meetings
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