Senior Scientist II, Toxicologist
BioMarin Pharmaceutical Inc.
Summary
The Pharmacology and Toxicology Department at BioMarin is seeking a Senior Scientist 2 to provide nonclinical pharmacology and toxicology expertise for the development of BioMarin's small molecule and biologic drug candidates. This individual will provide scientific leadership and play a pivotal role providing nonclinical expertise in support of all phases of the drug development process from late-stage research through market application and commercialization.
Job description
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, 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
- Excellent written and verbal communication skills
- Ability to build/foster productive cross-functional collaborations both within and external to BioMarin
Education
Required: Doctorate (Ph.D.) or equivalent experience in toxicology, pharmacology or a related, relevant discipline. Board Certification in Toxicology is highly preferred.
Experience
- 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, as well as a 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
- Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities
- Strong communication (verbal and written) skills
- Experience and ability to work collaboratively in cross-functional teams
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, as well as a 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
- Strong critical, scientific, and strategic thinking skills; Strong problem solving and decision making abilities
- Strong communication (verbal and written) skills
- Experience and ability to work collaboratively in cross-functional teams
Company overview
BioMarin Pharmaceutical Inc. is a leading global biotechnology company headquartered in San Rafael, California, specializing in the development and commercialization of innovative therapies for rare genetic diseases. Founded in 1997, the company has established itself as a pioneer in enzyme replacement therapies (ERTs) and genetic medicine, with a focus on addressing the root causes of serious, life-threatening conditions primarily affecting children. BioMarin's portfolio includes eight commercial therapies targeting various rare disorders, including mucopolysaccharidosis, phenylketonuria (PKU), achondroplasia, and hemophilia A. The company's groundbreaking work includes being the first to provide therapeutics for mucopolysaccharidosis type I and phenylketonuria. With approximately 3,000-3,500 employees worldwide and operations across North America, Europe, Asia Pacific, and South America, BioMarin maintains a strong commitment to transforming lives through genetic discovery. The company's research and development efforts continue to advance a robust pipeline of product candidates, applying a science-driven, patient-forward approach to address broader groups of genetic disorders.