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Principal / Senior Scientist II, Immunogenicity

BioMarin Pharmaceutical Inc.


Location:
San Rafael, California 94901
Date:
04/04/2017
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
BioMarin Pharmaceutical Inc.
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Job Details

The Immunogenicity Assessment Group within BioMarin is seeking an immunologist with drug development experience to provide risk-based immunogenicity assessments and data interpretation for novel biologic drug development programs. The position will influence and advance our immunogenicity risk mitigation strategies through scientific leadership, internal and external collaborations, and application of scientific data to inform risk and mitigation approaches. This is not a laboratory-based role. This role focuses on risk assessment, clinical interpretation, and strategic interactions. This role will interact and collaborate with diverse functional groups within Biomarin, including Research, Pharmacology/Toxicology, Clinical Pharmacology, BioAnalytical Sciences, Clinical Sciences, Pharmacovigilance, BioMetrics, Regulatory, and Medical Affairs.

RESPONSIBILITIES

·Provide immunology and immunogenicity expertise to biologic drug development programs from early stage research to post-marketing

·Develop risk-based immunogenicity assessment strategies for novel biologic therapeutics with a focus on clinical impact

·Analyze and interpret immunogenicity data from nonclinical and clinical studies to determine clinical relevance and translatability

·Lead analysis efforts across clinical trials and biologic programs to better understand emerging immunogenicity trends across modalities and indications

·Represent the Immunogenicity Assessment function on multiple cross-functional development teams and contribute to strategic and scientific planning and execution

·Author Immunogenicity sections of regulatory submissions, such as clinical study reports, investigator brochures, integrated immunogenicity reports, and BLA/MAA dossiers, etc.

·Manage interactions with key opinion leaders and regulatory agencies on immunogenicity-related issues

·Present results and key messages of immunogenicity findings to internal teams, executive management, external collaborators, and regulatory authorities

·Author immunogenicity-focused publications and present findings at conferences and other public forums

EXPERIENCE

· Expert immunologist with experience in the field of immunogenicity assessment of protein therapeutics

· At least 8 years of drug development experience in pharmaceutical or biotechnology industry

· Firm understanding of ICH immunogenicity guidelines, monitoring strategies, and commonly-used immunogenicity assays

· Strong analytical skills and proficient at data analysis and interpretation

· Broad understanding of clinical implications associated with anti-drug immunogenicity responses

· Experience authoring immunogenicity sections of regulatory submissions

· Experience interacting with regulatory authorities regarding immunogenicity assessment strategy and data interpretation

· Proficient at communicating efficiently and effectively within cross-functional teams and with executive management and external experts

· Excellent presentation skills, with proven track record of external presentations at conferences and within public forums

· Highly collaborative with effective influencing/partnering skills in a complex, multi-discipline organization 

· Highly motivated and comfortable working independently in a fast-paced environment

· Proven track record of publishing high-impact scientific articles

Education

· PhD in immunology or related field

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