Job Posting Details


Summary

LOCATION: New York, NY

STATUS: Regular, Full-Time

REPORTS TO: Vice President, Clinical Development

SUMMARY: Involvement in all aspects of clinical trial design and execution, including authoring protocols, medical content and leadership of the clinical studies, with particular focus on EU, site initiation, medical monitoring (incl. review adverse events) and data interpretation and reporting.

Essential Duties and Responsibilities

  • Support clinical development strategic planning activities and translate strategic decisions into actionable plans.
  • Create clinical development plans (CDPs), including translational and biomarker, as well as immuno-response assessment studies, and implement properly approved clinical protocols.
  • Design scientifically rigorous and cost-effective clinical development programs.
  • Act as the medical monitor to assess study progress and be available for addressing and resolving all clinical issues (along with the CRO and the clinical site medical teams) that might arise from implementation of corporate-sponsored clinical trials.
  • Lead the analyses and data evaluation process to report progress and present to senior management.
  • Review and/or prepare various documents, such as statistical analysis plans (SAPs), clinical study protocols, clinical study reports (CSRs), other internal technical and clinical reports (e.g., interim analyses), NDA, BLA and IND summary documents, Safety and Annual reports (ARs), and responses to regulatory agencies according to FDA and ICH guidance and standards.
  • Manage safety monitoring in clinical studies and manage pharmacovigilance/ drug programs.
  • Ability to maintain collaborative relationships with key investigators and institutions to support the company’s clinical development strategy.
  • Collaborate with and manage contractors, consultants and other external parties, as needed.
  • Ensure the clinical development program requirements and timelines are met; accomplish this through working closely and in a collaborative spirit with Clinical Operations, Finance, Regulatory Affairs and the CMO.

Requirements

MD Degree required, ideally with focus in Hematology/Oncology; 5-7+ years industry

experience including extensive experience in clinical trials and a thorough understanding of immunotherapies. Experience leading the design, conduct analysis and reporting of clinical studies. Must be highly organized and have excellent presentation and communication skills (written and verbal). Proficiency in MS Office Suite to compose PowerPoint presentations. Ability to travel as required.



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