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 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 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 Pharmacological Sciences Department at BioMarin is seeking a Sr. Principal / Staff Pathologist (Sr. / Executive Director level) with extensive drug development experience to provide veterinary pathology expertise for the development of BioMarin's gene therapy, small molecule and biologic drug candidates. This individual will provide scientific leadership and play a pivotal role in providing pathology expertise in support of all phases of the drug development process from late-stage research through market application.

The successful candidate will have a strong anatomic pathology background with demonstrated experience in drug development and toxicologic pathology. The candidate will interact with pharmacologists, toxicologists and other scientists across Research and Early Development in order to provide a balanced assessment of the risk/benefit profile associated with a drug candidate's advancement. The individual will be responsible, in collaboration with other scientists, for the design, implementation and interpretation of GLP and non-GLP studies to ensure comprehensive pharmacological and safety profiling of drug candidates. The successful candidate will have experience providing context of findings to senior management and offering insights for clinical endpoints and strategies. The candidate will communicate and present scientific data and conclusions, along with their potential translatability to humans, to project teams, external collaborators, and the scientific community.

RESPONSIBILITIES:

• Contribute to design/implement of GLP and non-GLP nonclinical studies of small molecule and biologic drug candidates; analyze, interpret, report and communicate study data
• Conduct gross and microscopic examination of animal tissues from pharmacology and toxicology studies and animal models of disease; interpret and determine significance of results in context with other relevant study data; Conduct pathology peer reviews at CROs
• Report pathology data in accordance with GLPs and other relevant regulations
• Collaborate in the investigation of mechanisms of disease, drug action, and toxicity
• Review and contribute to study synopses, protocols, study reports and regulatory documents
• Collaborate with various BioMarin functions, CROs, university or analytical laboratories, business partners, as necessary to ensure appropriate/timely progression of projects
• Effectively communicate nonclinical findings and their relevance to senior management, project teams, collaborators, and regulatory agencies (i.e. FDA, EMEA, MHRA)
• 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: Doctor of Veterinary Medicine (DVM/VMD) and doctorate (Ph.D.) or equivalent experience in pathology or a related, relevant discipline. American College of Veterinary Pathologists (ACVP) board certification in anatomic pathology.

EXPERIENCE:

• Nonclinical anatomic and toxicologic pathology background and 12+ years of experience in the pharmaceutical, CRO, and/or biotechnology field for a Scientist level.
• Strong understanding of drug development, regulatory process, and Good Laboratory Practices (GLPs)
• Experience supporting the development of gene therapies, small molecules, biologics and/or other therapies, including determining non-clinical program strategy and design.
• Experience with the preparation of regulatory submissions 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

Education & Level Qualifications: Sr. Principal Scientist 2:

• PhD or equivalent relevant experience plus 12+ years industry experience
• This is equivalent to a Sr. Director

Staff Scientist:

• PhD or equivalent relevant experience plus 15+ years of industry experience
• This is equivalent to an Executive Diretor

Apply Here: https://www.Click2Apply.net/w2bhm5jkm838rxj4

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