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Nonclinical Development Director

2 months ago

London, Greater London, United Kingdom Proclinical Staffing Full time

Job Summary:

Proclinical Staffing is seeking a dedicated and innovative individual to lead a Nonclinical Development team. This role is pivotal in shaping the company's nonclinical strategy and overseeing the execution of non-clinical programs to advance the pipeline of innovative RNAi medicines.


Key Responsibilities:

  • Develop and execute non-clinical study strategies, designs, and protocols for the pipeline, ensuring compliance with regulatory requirements.
  • Deliver high-quality data packages to regulatory authorities to support clinical development, including experimental approach, data packages, and regulatory content preparation.
  • Collaborate with cross-functional project teams to design and execute non-clinical development strategies, ensuring alignment with business objectives.
  • Establish and maintain effective relationships with Contract Research Organizations (CROs) and consultants to design and execute nonclinical studies.
  • Lead nonclinical project managers and ensure all nonclinical programs are completed within established timelines, meeting quality and regulatory standards.
  • Prepare and present nonclinical project updates to the Executive Team, highlighting key milestones and challenges.
  • Collaborate closely with finance and operations teams to ensure seamless execution of nonclinical programs.
  • Author, review, and approve scientific reports that support regulatory documents, ensuring accuracy and compliance.
  • Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances, ensuring business continuity.


Requirements and Qualifications:

  • PhD in pharmacokinetics, biology, pharmacology, or a related discipline.
  • Deep understanding of drug metabolism, ADME concepts, pharmacokinetics, and bioanalytical principles.
  • Extensive experience in nonclinical study design and execution within oligonucleotides, leading to regulatory submissions.
  • Strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
  • Experience working with nonclinical 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.