Principal Scientist / Sr. Scientist, Nonclinical Research and Development Strategy, Pharmacological Sciences - San Rafael, CA | Biospace
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Principal Scientist / Sr. Scientist, Nonclinical Research and Development Strategy, Pharmacological Sciences

BioMarin Pharmaceutical Inc.

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Location:
San Rafael, CA
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
12660
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

Description    
       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 Development Sciences group is responsible for everything from research and discovery to post-market clinical development. Development Sciences 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.
            Summary        The Pharmacology and Toxicology Department at BioMarin is seeking a Principal Scientist to provide nonclinical expertise for the development of BioMarin's small molecule and biologic drug candidates.  This individual will provide scientific leadership and play a pivotal role in the nonclinical development of BioMarin's pipeline from late-stage research for all phases of the drug development process including market application and commercialization.      The successful candidate will have an extensive background in pharmacology and toxicology as well as a strong understanding of Regulatory Practices that will provide broad-based support to align nonclinical efforts with the company's opportunistic philosophy of drug development. A successful candidate will support the strategic nonclinical development of BioMarin's therapeutics by creating a best-evidence synthesis of existing knowledge and by designing, implementing, interpreting, investigating pharmacological and toxicological relationships and reporting data that elucidates the nonclinical profile of drug candidates. This individual will work collaboratively with internal and external cross-functional subteams and consultants to implement and execute nonclinical development pathways from research to post market application for drug candidates. 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 is expected to support BioMarin's nonclinical studies which are conducted in multiple species under non-GLP and GLP conditions depending on the objective of the studies.  The successful candidate is responsible for the 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.      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.       RESPONSIBILITIES:        Map, contribute to and implement an overall nonclinical program strategy to support clinical candidates 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 regulatory regions (i.e. FDA, EMEA, MHRA, ROW)      Managerial responsibilities include supervision of Pharm/Tox scientific staff and team development      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 outside laboratories and regulatory agencies      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.

Requirements

EXPERIENCE:

Nonclinical pharmacology/toxicology background and 10+ years of experience in the pharmaceutical, CRO, and/or biotechnology field          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

EDUCATION:

Required:  Doctorate (Ph.D.) in pharmacology, toxicology or closely related field of study.       Board Certification in Toxicology is a plus.        ~BIO