Jobid=68b5f26a4a7c (0.0565)
I’m partnering with a growing mid-sized pharmaceutical company developing a pipeline of innovative oncology therapies now progressing toward first-in-human studies. They’re looking to appoint a Preclinical Development Lead – Toxicology & Safety, a pivotal role shaping nonclinical strategy and ensuring the scientific and regulatory robustness of programs advancing to the clinic.
This position suits an experienced toxicologist who enjoys combining scientific depth with strategic oversight – someone confident leading GLP/non-GLP studies, managing CROs, and contributing to regulatory submissions.
The Opportunity
- Lead the design and implementation of preclinical toxicology and safety pharmacology strategies across the oncology pipeline.
- Oversee GLP/non-GLP studies (in-house and outsourced) and ensure data quality and compliance.
- Integrate toxicology, PK/PD, and pharmacology findings to guide dose selection and clinical planning.
- Prepare and review nonclinical sections for IND/IMPD submissions.
- Act as subject-matter expert during regulatory interactions.
- Mentor scientists and shape the preclinical development function as the company scales.
Ideal Background
- PhD, DVM, or equivalent in Toxicology, Pharmacology, or related discipline.
- 8+ years’ experience in preclinical safety/toxicology within pharma or biotech.
- Proven track record managing outsourced GLP studies and CRO partners.
- Strong understanding of ICH/OECD guidelines and regulatory expectations for IND/CTA filings.
- Excellent communicator with the ability to translate data into strategic decisions.
- (Bonus) Experience within oncology or targeted therapies, and familiarity with translational safety assessments.
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