Senior / Principal Scientist, Immunogenicity - San Rafael, CA | Biospace
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Senior / Principal Scientist, Immunogenicity

BioMarin Pharmaceutical Inc.

San Rafael, CA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Areas of Expertise Desired:

Job 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.
       Provide leadership to immunogenicity assessment strategy and data interpretation for biologic drug development programs.
         Develop immunogenicity and safety assessment strategies for novel biologic therapeutics to determine the overall impact of anti-drug immune responses on safety and efficacy
         Provide strong leadership and management to immunogenicity initiatives and cross-functional drug development teams
         Provide immunology/immunogenicity expertise to the drug programs across developmental stages, including research, pre-clinical, clinical, and post-marketing
         Lead collaborations with nonclinical and clinical scientists to analyze, interpret, and communicate immunogenicity data to cross-functional groups in written and oral format
         Act as Immunogenicity Assessment and Pharmacological Sciences representative on Pharmacology, Clinical, and Development teams
         Lead writing efforts of Immunogenicity sections on clinical study protocols, statistical analysis plans, clinical study reports, investigator brochures, annual reports, and regulatory documents
         Lead investigative research efforts across clinical trials and biologic programs to better understand immerging immunogenicity trends from different drugs that fall into similar classes, ex. ERTs, gene therapies, etc.
         Manage interactions with key opinion leaders and regulatory agencies on immunogenicity-related issues



         8+ years of industry experience in biotechnology or pharmaceutical setting with solid understanding of the drug development process
         Extensive knowledge of immunology with expertise in cellular and humoral immune responses
         Expertise in one or more of the following scientific areas: inflammation, complement activation, immune complex formation, immune tolerance
         Firm understanding of ICH immunogenicity guidelines, monitoring strategies, and commonly-used immunogenicity assays
         Strong analytical skills and proficient at data analysis and interpretation
         Excellent verbal and written communication skills with adept interpersonal skills
         Proficient at communicating efficiently and effectively within cross-functional teams and with executive management and external experts
         Strong leadership and management skills


         PhD in immunology or related field, MD, or PharmD