Vice President, Clinical Development (MD)

Job Locations US-NJ-Florham Park
ID
2021-1308
Category
Clinical Development
Type
Regular Full-Time

Overview

Reporting to the Chief Medical Officer the VP of Clinical Development will oversee development programs from proof of concept to registration Phase 3 randomized studies and completion of post-approval commitments within the oncology therapeutic area.

Responsibilities

Responsibilities:

  • Responsible for oncology clinical development programs from POC to registration and completion of post-approval commitments.
  • Responsible for development of clinical protocols to support product drug candidates, strategy, data collection and management and final reports development in compliance with appropriate SOPs, regulatory and GCP standards.
  • Responsible for clinical trial execution including, data analysis and reporting to prepare documentation required for regulator and legislative drug approvals.
  • Provide ongoing medical monitoring for clinical trials, including assessment of eligibility criteria, toxicity management and drug safety surveillance.
  • Engage thought leaders, investigators, cooperative groups and other experts in constructive scientific and clinical dialogue around study design, study conduct and interpretation of clinical results.
  • Manage the preparation and/or review of data listings, summary tables, study results, study reports, regulatory documents, IND annual reports, IND safety reports, investigator brochures, and clinical development plans.
  • Coordinate the collection and analysis of clinical data, develop manuscripts for publication in peer-reviewed journals and prepare presentations for scientific conferences as well as for clinical study investigator meetings and expert clinical advisory meetings.
  • Interact with global regulatory agencies and responsible for authoring and/or reviewing relevant IND/BLA sections and generating responses as well as regulatory designation applications.
  • Ability to travel domestically and internationally to company, scientific, regulatory, investigator and other meetings.

 

Qualifications

Requirements:

  • An MD with preferred Board Certification in Oncology or Hematology
  • Minimum of 10 years relevant experience in drug development in pharma or biotech
  • Demonstrated experience leading the successful development of complex drug therapies on time, on budget, and with quality assurance and regulatory compliance
  • Strong scientific background in oncology
  • Experience in translational medicine, clinical pharmacology and biostatistics
  • A proven success record in oncology clinical research studies and trial design as well as the successful submission of IND’s.
  • Submission of marketing approval-directed filings, (BLA, NDA, MAA) preferred.

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