Senior Scientist II, Toxicologist

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San Rafael

BioMarin Pharmaceutical

Senior Scientist II, Toxicologist

Location: San Rafael, United States

Workstyle: Hybrid

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Who We Are

BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.

Guided by our purpose to develop medicines that make a profound impact on peopleâ€s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.

Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.

About Worldwide Research and Development

From research and discovery to post-market clinical development, our R&D engine 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.

The Pharmacology and Toxicology Department at BioMarin is seeking a Senior Scientist 2 to provide nonclinical pharmacology and toxicology expertise for the development of BioMarinâ€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 BioMarinâ€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 companyâ€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 candidateâ€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.Â

 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 BioMarinâ€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. Â
• Board Certification in Toxicology is highly preferred.

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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.Â
• 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.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ireland Safety Responsibility

Support the organisationâ€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.

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The salary range for this position is: $157,900 to $217,140. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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Recruitment Fraud Alert Notice

Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, email Applicant_accommodations@bmrn.com with your request.

This email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team â€" please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us at talentacquisition@bmrn.com.

Applicants, please do not use this email address to submit resumes â€" if you do so, you will be redirected to apply through the website.

Click here to review "EEO Is The Law" poster. Click here to review the Pay Transparency Nondiscrimination Statement. Click here to review the Notification of Employee Rights under Federal Labor Laws.

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