MBX Biosciences

MBX Biosciences

Scientist, Pharmacology and Toxicology

Carmel, Indiana or Burlington, MA

Sponsorship not specifiedDetected 16 days ago
PharmacologyFDA RegulatoryExperimental DesignAnimal StudiesRegulatory Affairs

About the role

  • The Scientist, Pharmacology and Toxicology, reporting to the Sr.
  • Director of Pharmacology & Toxicology is an individual contributor who works in a team environment (toxicology, pharmacology, medical/clinical, regulatory, CMC) in b iotech drug discovery and development.
  • In addition, the role will liaise with discovery and development colleagues and participate in development of the overall toxicology and pharmacology strategies.

Responsibilities

  • Support the conduct of preclinical toxicology programs for small and large molecules in discovery and development stages.
  • Propose and support the development of preclinical toxicology strategies to advance programs.
  • Interface with MBX regulatory affairs on documents for FDA and other regulatory bodies.
  • Provide tactical support for multiple project teams as they advance molecules from target discovery through lead optimization to clinical development.
  • Support writing of toxicology and pharmacology sections of regulatory documents, including but not limited to the IND, IB and BLA.
  • The position includes study design and monitoring, development of relationships with t oxicology CROs and u niversity d iscovery p harmacology activities, data review, data interpretation, and data presentations.

Requirements

  • Minimum of 5 years of related experience in biopharma or a CRO.

Benefits

  • Work with the clinical group to develop nonclinical timelines, and risk-benefit approaches for molecules selected to move forward to FIH trials.
  • Education & Qualifications

This listing is sourced directly from MBX Biosciences's careers page and normalized into a canonical job model.