Senior Director of Nonclinical Development

3 weeks ago

London, Greater London, United Kingdom Proclinical Staffing Full time
Job Summary

Proclinical Staffing is seeking a highly skilled and experienced Senior Director of Nonclinical Development to lead our Nonclinical Development team. This is a pivotal role that requires a strong understanding of nonclinical development strategies and the ability to oversee the execution of non-clinical programs to advance our pipeline of innovative RNAi medicines.

Key Responsibilities
  • Nonclinical Study Strategy and Execution: Oversee the development and implementation of nonclinical study strategies, including experimental approach, data packages, and regulatory content preparation.
  • Data Package Delivery: Ensure the delivery of high-quality data packages to regulatory authorities to support clinical development.
  • Cross-Functional Collaboration: Collaborate with cross-functional project teams to design and execute non-clinical development strategies.
  • CRO and Consultant Management: Establish and maintain effective relationships with CROs and consultants for the design and execution of nonclinical studies.
  • Project Management: Lead nonclinical project managers and ensure all nonclinical programs are completed within established timelines.
  • Reporting and Presentations: Prepare and present nonclinical project updates to the Executive Team.
  • Finance and Operations Collaboration: Collaborate closely with finance and operations teams.
  • Scientific Reporting: Author, review, and approve scientific reports that support regulatory documents.
  • Risk Management: Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.
Requirements
  • Education: PhD in pharmacokinetics, biology, pharmacology, or a related discipline.
  • Experience: Extensive experience in nonclinical study design and execution within oligonucleotides and leading to regulatory submissions.
  • Regulatory Knowledge: Strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
  • CRO Management: Experience working with nonclinical CROs to deliver fully costed agreements and study protocols.
  • Leadership and Communication: Strong project management, organizational, and leadership skills, with excellent communication skills in verbal and written English.

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