Head, Preclinical Development

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(SM)
Published: about 1 month ago
Expiry date: 01 August 2021

Responsibilities:

  • Lead the Preclinical development team including the core disciplines (Pharmacology, Non-Clinical Biology, DMPK/ and in vivo Pharmacology/Toxicology) to ensure high quality, scientifically rigorous, and timely delivery of the Non-Clinical IND package to best align with the clinical and regulatory strategy.

  • Serve as a spokesperson for programs and remain accountable for team deliverables and value creation.

  • Create and own a product development plan in partnership with functional leaders to govern project strategy.

  • Drive strategies to inform and advance discovery, development, and regulatory affairs.

  • 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.

  • Maintain project timelines with input from the functional departments and scientific project leaders, ensuring that project timelines align with corporate goals.

  • Proactively identify and communicate risks in the project timelines regarding key milestones and deliverables and work closely with the scientific and functional leaders to mitigate downstream impacts.

  • Assist scientific project leaders foster high-performing teams through the creation of team norms and operating principles.

  • Facilitate effective, science-based business decisions including scenario planning, highlighting all potential downstream impacts of strategic decision making (including resource allocation, team capacity, risk and overall portfolio management).

Salary: On application