Nonclinical Development Director

2 weeks ago

london city of london, United Kingdom Proclinical Staffing Full time
Job Title: Nonclinical Development Director

Proclinical is seeking a highly skilled and experienced Nonclinical Development Director to lead our team 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.
  • Collaborate with cross-functional project teams to design and execute non-clinical development strategies, delivering high-quality data packages to regulatory authorities.
  • Establish and maintain effective relationships with CROs and consultants to design and execute nonclinical studies, ensuring timely and cost-effective delivery.
  • Lead nonclinical project managers and ensure all nonclinical programs are completed within established timelines, meeting regulatory requirements and company standards.
  • Prepare and present nonclinical project updates to the Executive Team, ensuring transparent communication and stakeholder engagement.
  • Collaborate closely with finance and operations teams to ensure seamless integration of nonclinical development with business operations.
  • 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 and risk management.
Requirements:
  • 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.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. We are committed to delivering exceptional service and supporting our clients in achieving their business goals.

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