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Vice President, Clinical Development

Open Position

Vice President, Clinical Development

Overview

The VP Clinical Development will report to the Chief Medical Officer and will provide leadership for the clinical team and Elevar drug development programs. The successful candidate will provide medical and scientific expertise on the strategy, design, execution and interpretation of data from late-stage clinical solid tumor programs This leadership role will be responsible for the clinical development function; direct reports include one or more physicians and clinical scientists.

This individual will be responsible for ensuring that all studies are conducted with the highest level of ethical and safety standards and are in compliance with GCP and all regulatory policies. Duties include primary interactions with investigators, CROs. Other vendors, and development partners, functioning as the medical representative on the integrated project team, and providing medical consultation as needed across the Elevar portfolio of products and studies.

This individual will interact closely with company management. A genuine interest and understanding of the science, desire to work in a highly collaborative organization, and deep passion about making a difference in the lives of patients are essential. This position is 100% remote.

Responsibilities

  • Provide medical leadership for the clinical development function and for one or more oncology assets
  • Lead study team meetings and provide medical guidance to the clinical operations team in the execution of clinical trials
  • Evaluate scientific information and new ideas to assist in identifying new research opportunities
  • Secure, analyze and report on competitive intelligence related to successful conduct/execution of studies sponsored by other organizations and new data that may impact Elevar programs
  • Provide mentorship and development opportunities to others within Elevar
  • Responsible for resourcing clinical development programs within functional area
  • Responsible for medical monitoring of one or more clinical trials
  • Supervise one or more MDs and/or clinical scientists
  • Contribute to CDP for one or more assets
  • Represent clinical development to executive leadership, KOLs, investigators, regulatory agencies
  • Present findings internally and externally (eg, investigator meetings, regulatory agency meetings) acting as a spokesperson for Elevar
  • Work cross-functionally with clinical operations, biometrics and data management, drug safety, regulatory, clinical pharmacology, medical affairs, etc.
  • Successfully interface with development partners
  • Contribute to determining global strategy for development of oncology assets
  • Author/review, in collaboration with other Elevar functions, protocols, ICFs, CRFs, CSRs, IBs, DSURs, PSURs, regulatory packages, NDAs, MAAs
  • Review and interpret clinical trial data
  • Prepare manuscripts, abstracts and presentations for scientific meetings

Requirements

  • MD (or equivalent) required
  • Training in oncology required; US fellowship and board-certification preferred
  • 8+ years’ experience in oncology clinical development, with experience in small and large pharma
  • Direct experience in authoring NDA/MAA
  • Global clinical trial experience, including Phases 1 through 3 studies
  • Experience supervising other physicians and/or clinical scientists
  • Extensive knowledge of oncology clinical drug development, including FDA regulations, statistics, safety, etc.
  • Experience in working with small molecule targeted agents; experience with VEGFR inhibitors a plus
  • Excellent written and verbal communication skills
  • Willing and able to travel, as needed

To Apply

Please send your resume and message to jrubin@elevartherapeutics.com.