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Nonclinical Development Director
2 months ago
Proclinical is seeking a dedicated and innovative individual to spearhead 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.
Key Responsibilities:
- Develop and execute non-clinical study strategies, including experimental approaches, 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 strategies.
- Establish and maintain effective relationships with CROs and consultants for the design and execution of nonclinical studies.
- 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 within oligonucleotides and execution 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.
About Proclinical Staffing:
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 recruitment services to our clients and candidates.
