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Senior Executive Director, Clinical Development

Open Position

Senior Executive Director, Clinical Development

Job Summary

The Senior/Executive Director Clinical Development will report to the Vice President Clinical Development and will provide leadership for one or more 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 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.

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.

Job Details

  • Provide medical leadership 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
  • Responsible for resourcing assigned clinical development programs within functional area
  • Responsible for medical monitoring of one or more clinical trials
  • Contribute to CDP for one or more assets
  • Represent clinical development to 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 (This section should describe the major purpose/objectives of this position in the company. The key outcome measures for this position, how the position creates value, issues the position resolves, processes the position effects, the scope of the decision-making, any key metrics used in evaluating performance, etc.)

Candidate Requirements

  • MD (or equivalent) required
  • Training in oncology required; US fellowship and board-certification preferred
  • 5+ 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
  • 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.