Senior Scientist II or Principal Scientist, Regulatory / Safety ToxicologyLocation San Rafael, California Workstyle Open to Hybrid Apply
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
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 or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
The Pharmacology and Toxicology Department at BioMarin is seeking a Senior Scientist or Principal Scientist (Director Level) to provide nonclinical expertise regarding the development of BioMarin’s small molecules, biologics, and gene therapy candidates. This individual will provide scientific leadership and play a pivotal role from late-stage research through nonclinical development for all phases of the drug development process including market application and commercialization.
A successful candidate will lead the strategic development of BioMarin nonclinical therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating toxicity relationships 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 map complete development pathways from research to post market application for drug candidates. The resulting plans should result in the efficient execution of integrated nonclinical programs to support clinical development and regulatory submissions. Studies that support BioMarin’s nonclinical programs are conducted in multiple species under non-GLP and GLP conditions depending on the objective of the studies. Comprehensive analysis and interpretations of these studies are reported and defended to regulatory agencies in meetings and documents including the IND/CTA, annual reports, investigator brochures, special protocol assessments and market applications.
The successful candidate will have an extensive pharmacology/toxicology background as well as a strong understanding of Good Laboratory Practices (GLPs) that 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 lead or actively participate in representing Pharmacological Sciences on cross-functional project teams and/or project subteams. This individual will also participate in program initiatives that further the business objectives of the company.
- Contribute to and implement an overall drug development strategy to support nonclinical and clinical pharmacology development plans in support of all stages of drug development
- Design, implement, report and interpret nonclinical study data to support small molecules and biologics in late-stage research and all stages of nonclinical/clinical development
- Prepare study proposals, protocols, study reports and regulatory documents to support nonclinical development of BioMarin drug candidates
- Interact with CROs, university laboratories, analytical laboratories, collaborators, both internal and external to BioMarin, as necessary to ensure appropriate/timely progression of BioMarin nonclinical projects
- Collaborate with various BioMarin departments to ensure efficient cooperation with across functional areas
- 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 lead sub-teams
- Excellent written and verbal communication skills
- Ability to build and foster productive cross-functional collaborations both within and external to BioMarin.
- 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
- A minimum of ten years of nonclinical experience in the pharmaceutical and/or biotechnology field
- Strong understanding of drug development
- Excellent written and verbal communication skills
- Ability to build and foster cross-functional collaborations both withinand external to BioMarin.
- Established ability to interact with various regulatory agencies
- Established Drug Development Reputation
- Experience to support development of small molecules, biologics, and gene therapy
- Strong understanding of FDA and OECD Good Laboratory Practices
Required: Doctorate (Ph.D.) in toxicology or closely related field of study. Board Certification in Toxicology is a plus.
Sr. Scientist 2:
- PhD or equivalent relevant experience plus 8+ years of industry experience
Principal Scientist 1:
- PhD or equivalent relevant experience plus 10+ years of industry experience
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.