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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 highly skilled and experienced professional to lead our Nonclinical Development team. This role is crucial in shaping our company's nonclinical strategy and overseeing the execution of non-clinical programs to advance our pipeline of innovative RNAi medicines.

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 managers and ensure all non-clinical programs are completed within established timelines.
  • Prepare and present non-clinical 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 non-clinical 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.