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Nonclinical Development Director
3 months ago
Proclinical is seeking a dedicated and innovative individual to lead 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. The successful candidate will report to the VP, Head of Early-stage Development and will play a key role in driving the organisation's growth.
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.
- Establish and maintain effective relationships with CROs and consultants for the design and execution of nonclinical studies.
- Lead nonclinical project manager 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.
Key Skills and 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.
If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh on r.saleh@proclinical.com.
Apply Now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
