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Medical Leader (Director to Sr. Director)

Company: Fosun Pharma USA Inc.
Location: Jersey City
Posted on: June 18, 2022

Job Description:

This position will support Fosun Pharma Clinical and Medical assets by the successful execution of clinical development programs and deliverables in partnership across the organization; with external vendors; and with external academicians and collaboration partners as assigned by phase or therapeutic area. The candidate will report to the CMO ex-China.
As a medical leader in the project team, the candidate will be accountable for jointly developing clinical program strategy and help assure that activities are executed within the expected scope, budget, and timelines. Specifically, the candidate will work closely with colleagues in clinical development, program leadership, biometrics, clinical operations, pharmacovigilance, regulatory, and translational research, etc.
Job Responsibilities

  • Development of protocols for clinical studies
  • Preparation of clinical development plans
  • Drafting of clinical scientific documents such as clinical section of IND, Investigator Brochures, Annual Reports, Clinical Study reports, safety update reports and other FDA submissions, Risks/benefits analysis for applicable documents
  • Partner with clinical operations, pharmacovigilance, and other functional areas for the successful implementation and execution of clinical studies. Provide scientific expertise for the selection of investigators and vendors. Monitor, review and summarize safety and efficacy data in ongoing studies
  • Assist with study design for exploratory development
  • Will lead the clinical matrix teams for assigned compounds
  • Represent exploratory development on project teams
  • Develop relationships with appropriate consultants, contribute to or perform therapeutic area/indication research and competitor analysis
  • Interpret clinical data, prepare abstracts, and present data at scientific meetings, both internally and externally
  • Support budget planning and management
  • Train internal colleagues, CRO staff, and study site staff on the therapeutic area update, molecule overview, and/or clinical protocol
    Minimum Requirements
    • A medical degree (M.D./Ph.D, M.D., D.O., or equivalent) with significant scientific research experience required
    • At least 5 or more years of drug development experience within biotech/pharmaceutical companies are required
    • Prior industry Oncology Drug Development experience a plus, specifical experience in conducting phase I/II clinical trials and in-depth understanding of relevant regulatory health authority expectations and regulations
    • Ability to multi-task and work in a fast-paced environment
    • Excellent written and oral communication skills
    • Knowledge of GCP and ICH guidelines
    • Strong Analytical ability
    • Flexibility to work with colleagues in multiple geographic locations
    • A strategic leader with demonstrated success in building, managing, and developing individuals and teams is preferred
    • Experience with the development and support of related SOPs and policies is expected

Keywords: Fosun Pharma USA Inc., Jersey City , Medical Leader (Director to Sr. Director), Executive , Jersey City, New Jersey

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