Senior Director, Head of Safety Assessment

Position Details

  • Job Title: Senior Director, Head of Safety Assessment
  • Location: New York
  • Job Category: Preclinical Development

JOB SUMMARY

We are seeking a highly creative, self-motivated safety assessment leader with significant experience in drug discovery and development to work as a member of an integrated team utilizing a novel platform for the discovery of new drug targets leading to transformational therapeutics.  The successful applicant will report to the Sn VP – Preclinical Development, contribute to the drug discovery process from target validation through clinical development, and have the unique opportunity to impact both the strategy and execution of multiple therapeutic programs driven by Kallyope’s cutting-edge biology on the gut and gut-brain axis. 

Successful candidates for this position will have a passion for developing and executing integrated nonclinical safety assessment strategies from discovery support through clinical development and a track record of driving results.  Ability to think creatively and solve problems is a must. 

KEY RESPONSIBILITIES

  • Serve as the safety expert on internal project teams
  • Collaborate with drug discovery scientists to advance programs from target validation through lead optimization including strategy setting and resource prioritization for safety studies to support candidate nomination
  • Design and execute investigative pharmacology studies to address potential safety liabilities (mechanism- and non-mechanism-based) in support of risk/benefit assessments
  • Oversee the design, conduct and interpretation of in vivo and in vitro studies to support safety pharmacology and toxicology requirements of regulatory authorities
  • Provide strategic guidance to project teams and senior management including evaluation and potential impact of safety results on program and clinical/regulatory strategy
  • Prepare summary reports for regulatory submissions and assist in the preparation of safety sections for Investigational New Drugs (INDs), annual reports, and Investigator Brochures (IBs)
  • Work closely with contract research organizations to develop assays and monitor ongoing studies

QUALIFICATIONS AND EDUCATION REQUIREMENTS

You must have:

  • PhD in pharmacology or related discipline, or equivalent industrial experience
  • Prior experience (7 to 10+ years) in drug discovery and development including preclinical safety evaluation of small molecule drug candidates
  • Expertise in the design and interpretation of safety pharmacology studies
  • Discovery / development project team experience
  • Familiarity with relevant health authority guidance for nonclinical safety evaluation
  • Experience with the writing of technical reports in support of regulatory filings
  • Demonstrated, active network with research centers, CROs, consultants and key opinion leaders
  • Excellent communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, senior leadership, and board meetings
  • Demonstrated scientific productivity and impact, as evidenced by strong publication record and successful execution of regulatory submissions, and ability to work effectively in a collaborative setting

Additional preferred experience includes:

  • Experience with gut-targeted compounds
  • Experience with drug candidates from multiple therapeutic areas
  • Experience with preclinical safety strategy for combination products

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