Director - DMPK and clinical pharmacology

Natick, Massachusetts

Position closed

Allorion Therapeutics is seeking a talented Director or Senior Director to lead the DMPK function and interact with research and development teams to advance Allorion’s programs. This position has responsibility to ensure that DMPK assessments for research compounds are conducted to support advancement to development candidates and to progress development candidates to registrations. The Head of DMPK is also responsible for overseeing the preparation of DMPK sections of regulatory submissions and serves on project teams.

  • Oversee DMPK activities
  • Develop close and collaborative working relationships across functions especially with toxicology, clinical and pre-clinical pharmacology groups
  • Ensure adequate DMPK representation on project teams and integration of DMPK insights into clinical programs and alignment of nonclinical DMPK and clinical activities related to drug metabolism and pharmacokinetics
  • Collaborate with research to develop critical pathways to select development candidates
  • Design DMPK studies to support clinical trials and product registration
  • Provide oversight for preparations of DMPK portions of regulatory submissions and clinical documents
  • Interact with regulatory agencies on drug metabolism and pharmacokinetic issues related to development projects
  • Critically evaluate project data while rigorously making data-driven Go/No-go decisions, including identification of resource constraints and bottlenecks
  • Promote a group culture of agility, pro-action, collaboration and innovation
  • Ph.D. in a related field
  • 10+ years of drug discovery experience in the pharmaceutical industry
  • Ability to work within interdisciplinary teams
  • Communication in a clear and concise manner both internally and externally
  • Strong organizational skills and the ability to manage multiple tasks
  • Experience in preparing regulatory submissions and supportive documents
  • Demonstration of highly successful project execution across disease areas using in-house and/or CRO resources leading to preclinical candidates for further clinical development
  • Impeccable attention to detail, and excellent ability to perform hands on experiments, research/design/organize projects and maintain detailed documentation
  • Able to provide leadership on a cross-functional team
  • Possess effective verbal, written, and interpersonal communication skills
  • Strong understanding of the drug discovery process and demonstrated leadership on cross-functional teams