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Senior Director of Nonclinical Development

2 months ago

South East England, United Kingdom Proclinical Staffing Full time

Job Summary:

Proclinical Staffing is seeking a highly experienced and innovative Nonclinical Development Director to lead our RNAi medicines pipeline. This is a pivotal role in shaping our nonclinical strategy and overseeing the execution of non-clinical programs.

Key Responsibilities:

  • Develop and execute non-clinical study strategies, designs, and execution plans for our pipeline.
  • Deliver high-quality data packages to regulatory authorities to support clinical development.
  • Collaborate with cross-functional project teams to design and execute non-clinical development strategies.
  • Establish and maintain effective relationships with Contract Research Organizations (CROs) and consultants for non-clinical study design and execution.
  • Lead nonclinical project managers and ensure all non-clinical programs are completed within established timelines.
  • Prepare and present non-clinical project updates to the Executive Team.
  • Collaborate closely with finance and operations teams.
  • Author, review, and approve scientific reports that support regulatory documents.
  • Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.

Requirements:

  • PhD in pharmacokinetics, biology, pharmacology, or a related discipline.
  • Deep understanding of drug metabolism, ADME concepts, pharmacokinetics, and bioanalytical principles.
  • Extensive experience in non-clinical study design and execution within oligonucleotides and leading to regulatory submissions.
  • Strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
  • Experience working with non-clinical CROs to deliver fully costed agreements and study protocols.
  • Commitment to generating data of the highest integrity, complying with regulatory requirements and ethical standards.
  • Strong project management, organizational, and leadership skills.
  • Excellent communication skills in verbal and written English.