Executive / Senior Director, Pharmacological SciencesLocation San Rafael, California Apply
BioMarin’s Research & Early Development (RED) group is responsible for progressing candidates from discovery into clinical development. Research & Early Development involves all non-clinical and clinical bench research and the associated groups that support the data interpretation. 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.
BioMarin is seeking a seasoned, Senior Director-level toxicologist to lead our Pharmacological Sciences Department within the Translational Sciences Division. This individual will be responsible for the oversight of toxicology, safety and large animal pharmacology studies needed to support the development of gene therapies, biologics, small molecules, and anti-sense oligonucleotides. As head of the Pharm. Sci. function, this leader will be accountable for the design, implementation and interpretation of studies demonstrating the pharmacological/toxicological profile of drug candidates. These studies will coordinate investigations across multiple species under appropriate non-GLP or GLP regulations and the role will include some Test Site Management responsibilities. The leader will have a proven track record for defending strategy to senior executives and coordinating studies to support applications and registrations, as well as represent the function at interactions with global health authorities.
The Head of Pharmacological Sciences will be expected to lead by example and interact collaboratively with scientists and department heads across Research and Clinical Development to inform a balanced risk/benefit profile for all drug candidates. A successful candidate will be a person who actively seeks feedback, adapts quickly to emerging information, looks for opportunity to make an impact, and has a philosophy of perpetual improvement. As a department head this person will join the Translational Sciences Leadership Team and is expected to help unite Translational Sciences departments to drive toward a common vision.
- Lead a group of Bachelors-to-PhD level scientists in providing comprehensive non-clinical safety and pharmacology strategies to support development of BioMarin drug candidates. Support career development opportunities for staff to maintain and expand expertise.
- Oversee the design, implementation, interpretation, and communication of non-clinical study data supporting benefit/risk assessments across programs.
- Review study proposals, protocols, and study reports to support non-clinical development of pipeline assets, mindful of 3R approaches.
- Supervise the authoring and reporting of non-clinical sections for IND/CTAs, BLA/MAAs, annual reports, Investigator Brochures, and any related incoming inquiries from health authorities.
- Leverage CROs, university collaborators, and external network to progress non-clinical programs according to timelines.
- Ensure the appropriate use of Good Laboratory Practices for in-life and pathology/histology portions of studies and ensure the proper training of involved staff.
- Effectively communicate non-clinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies (i.e. FDA, EMA, MHRA, ROW).
- Build connections between Pharm. Sci. and other groups to foster collaborative, productive and integrated investigations.
- At least 12 years of toxicology experience in the pharmaceutical and/or biotechnology field including oversight of GLP studies.
- Multiple IND/CTA submissions for small molecules and biologics and experience with NDA/BLA/MAA submissions.
- Established external reputation with global health authority reviewers with track record of approved drugs.
- Deep expertise with interpretation and application of guidances and ICH standards.
- Strong understanding of FDA and OECD Good Laboratory Practices.
- Excellent verbal and written communication skills with ability to cogently prepare and present data in group settings, prepare formal reports, give and receive useful feedback.
- Required: Doctorate (Ph.D.) in toxicology or closely related field of study with Board Certification in Toxicology.
- AND/OR Veterinarian (D.V.M.) with Board Certification in Pathology
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.