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Scientific. Clinical. Software Engineering

Medical Review Physician

New Jersey All, NJ

Job Type: Clinical Job Number: JN -062020-26913 Region: New Jersey All

Job Description

  • Matrix management responsibilities across the internal and external network
  • Manages Phase I-III studies and manages multiple complex studies with demonstrated decision making capabilities
  • Provides medical and scientific expertise to cross-functional colleagues
  • Ability to present clearly in scientific and clinical settings
  • Contributes to and is key member of a high performing Study Delivery Team (SDT) and may be a member of the Clinical Development Team (CDT)
  • Conducts medical data review of trial data, including eligibility review
  • Responsible for site interactions in partnership with the Clinical Scientist for medical questions and education (including safety management guidelines)
  • Responsible for assessment of key safety-related serious adverse events in partnership with GPVE and oversees safety narratives
  • Collaborates with CS and inputs into protocols, providing medical strategic oversight in protocol development (input on inclusion/exclusion criteria and other safety-related clinical considerations)
  • In collaboration with the CDL, designs and develops clinical plans and protocols with a strong strategic focus based on knowledge of the asset/drug, disease area and relevant science in order to meet regulatory and disease strategy targets
  • Leads the analysis of benefit/risk for clinical development protocols in a matrix team environment working in partnership with Clinical Scientists (CS)
  • Provides input into CTP and overall clinical development plan strategy
  • Provides medical accountability and oversight of a group of studies
  • Partners with CS to support executional delivery of studies (e.g., site activation, enrollment status, as well as adjudication for protocol violations, significant, non-significant deviations etc.)
  • Identifies and builds relationships with principal investigators
  • Identifies and cultivates thought leaders (TLs) in order to gain their inputs on emerging science in drug and biomarker research, disease knowledge and design of clinical development studies and programs
  • Maintains a strong medical/scientific reputation within the disease area
  • Has in depth knowledge of etiology, natural history, diagnosis, and treatment of the disorder
  • Keeps up-to-date in the disease area via attendance at scientific conferences and ongoing review of the literature
  • Keeps abreast of development and regulatory issues related to other competitive or relevant compounds in development and how our portfolio fits into the competitive landscape
  • Provides ongoing medical education in partnership with CS, protocol specific training, to support study team, investigators, and others
  • Provides strategic input into broad functional best practices and process improvement efforts
  • Contributes to key Health Authority interactions and advisory board meetings as Clinical Trial Physician
  • Authors/drafts clinical content for CSRs, regulatory reports, briefing books and submission documents to support closure, clinical narratives, reporting and filing of the study in partnership with CSs

Requirements:

  • MD required (or x-US equivalent) functional assignment as Clinical Trial Physician
  • 5 or more years Industry experience and/or clinical trials experience required
  • Subspecialty training in applicable therapeutic area
  • Expertise in using the scientific method to test hypotheses, including statistical design, analysis, and interpretation
  • Knowledge of the drug development process
  • Knowledge of the components needed for an effective clinical plan and protocols
  • Strong leadership skills with proven ability to lead and work effectively in a team environment


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