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Senior Director, Nonclinical Development
2 months ago
Job Title: Senior Director, Nonclinical Development
Job Summary:
Proclinical Staffing is seeking a highly experienced and innovative Senior Director to lead our 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:
- 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.