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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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 an experienced Scientist II to provide nonclinical pharmacology and toxicology expertise for the development of BioMarin's 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 research through market application and commercialization.
The 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 pharmacological / toxicological profile of drug candidates. This individual will work collaboratively with internal and external cross-functional sub-teams, collaborators and consultants to contribute to integrated development pathways throughout the drug development cycle.
The successful candidate will have a pharmacology / toxicology background as well as a strong understanding of pharmacological mechanisms of disease and will provide broad-based support to align nonclinical efforts with the company's opportunistic philosophy of drug development. The candidate will interact with collaborators and 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 sub-teams, external collaborators, and the scientific community. This individual will actively participate in representing Pharmacological Sciences on cross-functional project teams and/or lead project sub-teams.
Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development during all stages of drug development
Work closely with collaborators on animal models of disease including an in-depth understanding of disease etiology
Design, implement, report and interpret nonclinical study data of small molecule, biologic or other novel drug candidate constructs across all stages of development
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
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.
Nonclinical pharmacology / toxicology background and 5+ years of experience in the pharmaceutical, CRO, and/or biotechnology field at a Scientist level.
Expertise in in vivo pharmacology or experience with animal models of disease
Strong understanding of drug development and regulatory process, as well as a good 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 or non-GLP nonclinical pharmacology and 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
Required: Doctorate (Ph.D.) or equivalent experience in pharmacology, toxicology or a related, relevant discipline.