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VP, Non Clinical Development

3 months ago

Boston, Massachusetts, United States Seaport Therapeutics Full time

The VP, Non–Clinical Development leads the development and execution of the toxicology profiling of Seaport's drug candidates, including risk assessment /mitigation, development of innovative toxicology strategies, and communication of plans throughout the organization to ensure cross–functional alignment.

Seaport Therapeutics is a clinical–stage biopharmaceutical company advancing the development of novel neuropsychiatric medicines in areas of high unmet patient needs. The Company has a proven strategy of advancing clinically validated mechanisms previously held back by limitations that are overcome with its proprietary Glyph TM technology platform. All the therapeutic candidates in its pipeline of first and best–in–class medicines are based on the Glyph platform, which is uniquely designed to enable oral bioavailability, bypass first–pass metabolism and reduce hepatotoxicity and other side effects. Seaport is led by an experienced team that was involved in inventing and advancing KarXT and other neuropsychiatric medicines and are guided by an extensive network of renowned scientists, clinicians and key opinion leaders across neurological specialties. For more information, please visit .

Key Responsibilities

  • Lead toxicology and nonclinical development for Seaport's small molecule portfolio across preclinical and clinical development.
  • Formulate toxicology, DMPK, and ADME strategies to integrate with Seaport teams to advance programs.
  • Represent non–clinical development on project teams and interface with internal stakeholders in discovery and development, as well as interface with regulatory agencies.
  • Oversee the design and conduct of outsourced toxicology, ADME and safety pharmacology studies.
  • Analyze and interpret nonclinical toxicology and safety data; summarize and communicate findings, as well as provide guidance on follow–up/mitigation strategies.
  • Spearhead investigative efforts to elucidate mechanism of toxicity as needed.
  • Manage collaborations with CROs and consultants to support non–GLP and GLP studies.
  • Review and edit draft study reports and ensure timely finalization.
  • Author high quality regulatory documents including contributions to IND, CTA, BLA, NDA, IB, as well as contribute to communications with regulatory agencies.
  • Participate in the preparation of posters, abstracts, and manuscripts for publication.
  • Perform all duties in keeping with Seaport's values, policies, and all applicable regulations. Qualifications
    • PhD in Toxicology, Biology, Pharmacology, or other relevant field with minimum 12 years of professional/industry experience in toxicology–related research and/or drug discovery and development.
    • Certified Diplomate of the American Board of Toxicology preferred.