Senior Scientist I or II, NonClinical Pharmacology & Toxicology
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin's Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients' lives. The Pharmacology and Toxicology Department at BioMarin is seeking a Senior Scientist to provide nonclinical pharmacology and toxicology expertise for the development of BioMarin's biologic, small molecule and/ or novel 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. A successful candidate will contribute to the strategic development of BioMarin's therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating and reporting data that elucidates the pharmacologic/toxicologic profile of drug candidates. This individual will work collaboratively with internal and external cross-functional subteams, collaborators and consultants to contribute to integrated development pathways including regulatory submissions throughout the drug development cycle. Comprehensive analysis and interpretations of these studies are reported and defended to regulatory agencies in meetings and documents such as briefing documents, IND/CTA, annual updates, investigator brochures, special protocol assessments and market applications. The successful candidate will have a strong pharmacology/toxicology background as well as a good understanding of Good Laboratory Practices (GLPs) and will provide broad-based support to align nonclinical efforts with the company's opportunistic philosophy of drug development. The candidate will interact with scientists across the company in order to provide a balanced assessment as to the risk/benefit profile associated with a drug candidate's advancement. The individual will be responsible for the planning, implementation and organization of nonclinical studies along with the use of drug exposure to bridge across species, presentation of data (written and verbal) to cross-functional core teams and subteams, external collaborators, and the scientific community. This individual will actively participate in representing Pharmacological Sciences on cross-functional project teams and/or lead project subteams.
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, EMA, PMDA) 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 8 years experience in the pharmaceutical 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 novel therapies (ie gene therapy), 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
BioMarin is an Equal Opportunity Employer #LI-JL1