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Content Development Director

2 months ago

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

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.

The successful candidate will report to the VP, Head of Early-stage Development and will play a key role in driving the organisation's growth.

Key Responsibilities:
  • Oversee non-clinical study strategy, design and execution for the pipeline, including experimental approach, data packages, and regulatory content preparation.
  • Deliver high-quality data packages to regulatory authorities to support clinical development.
  • Collaborate with cross-functional project teams for the design and execution of non-clinical development strategy.
  • Lead nonclinical project manager and ensure all nonclinical programs are completed within established timelines.
  • Prepare and present nonclinical project updates to the Executive Team.
  • Author, review and approve scientific reports that support regulatory documents.
Requirements:
  • PhD in pharmacokinetics, biology, pharmacology or a related discipline.
  • Extensive experience in nonclinical study design within oligonucleotides and execution leading to regulatory submissions.
  • Strong knowledge of global regulatory requirements, with prior experience supporting regulatory submissions.
  • 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.