​Head of Non-Clinical Development

Location Boston
Discipline: Regulatory Affairs
Job type: Permanent
Salary: £Salary: On application
Contact name: Sam Murphy

Contact email: sam.murphy@rbwconsulting.com
Contact phone: 16179821238
Job ref: 21400
Published: about 1 month ago
Expiry date: 14 May 2021

The Role:

  • Lead the nonclinical development team, including the core disciplines (DMPK/Clinical Pharmacology, Nonclinical Biology, and in vivo Pharmacology/Toxicology) to ensure high quality, scientifically rigorous, and timely delivery of the nonclinical IND package to best align with the clinical and regulatory strategy. Team leadership occurs in a matrixed environment, without direct reports from these line functions.

  • Drive strategies to inform and advance drug discovery, drug development, and regulatory affairs through the entirety of the nonclinical and clinical development of a molecule.

  • Provide leadership to inform experimental design, aid in data interpretation, and the synthesis of cohesive program strategies across nonclinical disciplines.

  • Provide leadership around the design, execution, interpretation, and reporting of toxicity and safety pharmacology studies including assessment of potential relevance of findings on human safety.

  • Collaborate with Clinical Operations, Clinical Development, and Regulatory Affairs around IND preparation to ensure team-based approach with efficient workflow.

  • Engage in established collaborations and represent the company in external facing roles as the Nonclinical Lead, including global health authorities.

  • Management of cross-functional stakeholders to foster team consistent with company core values

  • Mentor, supervise, and encourage development of scientists working in pre-clinical development.

  • Additional duties and responsibilities as required.

Salary: On application