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Nonclinical Development Director
2 months ago
Job Summary:
Proclinical Staffing is seeking a highly experienced and innovative Nonclinical Development Director to lead our RNAi medicines pipeline. This is a pivotal role in shaping our nonclinical strategy and overseeing the execution of non-clinical programs.
Key Responsibilities:
- Develop and execute non-clinical study strategies, designs, and execution plans for our RNAi medicines pipeline.
- Deliver high-quality data packages to regulatory authorities to support clinical development.
- Collaborate with cross-functional project teams to design and execute non-clinical development strategies.
- Establish and maintain effective relationships with Contract Research Organizations (CROs) and consultants for nonclinical study design and execution.
- Lead nonclinical project managers and ensure all nonclinical programs are completed within established timelines.
- Prepare and present nonclinical project updates to the Executive Team.
- Collaborate closely with finance and operations teams.
- Author, review, and approve scientific reports that support regulatory documents.
- Develop contingency plans and backup scenarios to proactively mitigate unforeseen circumstances.
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 and 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.
