Description

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.

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 pharmacology/toxicology background as well as a strong 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, 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

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.