Senior Scientist II, Toxicologist

About This Role

This senior scientist role provides nonclinical pharmacology and toxicology expertise for the development of BioMarin's small molecule and biologic drug candidates. The individual will offer scientific leadership and play a pivotal role in providing nonclinical expertise to support all phases of the drug development process, from late-stage research through market application and commercialization. The position suits a candidate with a pharmacology/toxicology background and a strong understanding of Good Laboratory Practices (GLPs).

Responsibilities

• Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development
• Design, implement, report and interpret nonclinical study data of small molecule, biologic or other novel drug candidate constructs
• Prepare study synopses, protocols, study reports and regulatory documents to support nonclinical development of BioMarin's drug candidates
• Interact/collaborate with various BioMarin functions, CROs, university or analytical laboratories, and business partners, as necessary to ensure appropriate/timely progression of BioMarin projects
• Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies (i.e. FDA, EMEA, MHRA, ROW)
• Participate in multi-disciplinary drug development teams and may lead sub-teams
• Build/foster productive cross-functional collaborations both within and external to BioMarin
• Plan, implement and organize nonclinical studies along with the use of drug exposure to bridge across species
• Present data (written and verbal) to cross-functional core teams and subteams, external collaborators, and the scientific community
• Actively participate in representing Pharmacological Sciences on cross-functional project teams and/or lead project subteams

Requirements

• Doctorate (Ph.D.) or equivalent experience in toxicology, pharmacology or a related, relevant discipline
• Board Certification in Toxicology is highly preferred
• Nonclinical pharmacology/toxicology background and 5+ years industry experience in the pharmaceutical, CRO, and/or biotechnology field for a Scientist level
• Strong understanding of drug development and regulatory process
• Strong understanding of Good Laboratory Practices (GLPs)
• Experience supporting the development of small molecules, biologics and/or other therapies, including determining non-clinical program strategy and design
• Experience with the preparation of regulatory submissions (IND/CTDs, NDA/BLA, etc.) and communicating/interacting with health authorities desirable
• Experience in the design, conduct, and interpretation of GLP and non-GLP nonclinical toxicology studies