Description

Who We Are 
 
 From research and discovery to post-market clinical development, our WWRD engine 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 genetic diseases. 

The Director/Associate Director of Clinical Immunogenicity will report to the Head of Clinical Immunology and will play a senior leadership role in the organization. This individual will be a Clinical Immunology leader on project teams and is expected to work with cross functional stakeholders from Research, Translational and Clinical Sciences, driving immunogenicity assessment, monitoring and mitigation strategy for candidate pipeline molecules. Expertise in the complement pathway and complement mediated downstream clinical effects is highly desirable. Additionally, experience with gene and anti-sense oligonucleotide therapy is also highly desirable. Additionally, the individual will be accountable for Clinical Immunology aspects of regulatory filings along with presentation of results and key messages to internal teams, executive management and external collaborators. This individual will assume the role of a cross-functional early development team lead for BMRN program(s). The role will also influence overall strategy for regulatory approval and life cycle management of the product, through subject matter expertise, scientific leadership and participation in cross-functional teams. This role will require expertise authoring scientific documents including correspondences with regulatory agencies, regulatory documents and scientific publications. This role requires strong interpersonal skills and an ability to work in a dynamic cross-functional team environment. Candidates for this position must be able to analyze and understand complex scientific data quickly and condense the information into straightforward, clinically relevant messages for external and internal communication. Candidates for this position must have cross-functional team leadership experience.

RESPONSIBILITIES

•  Clinical Immunology leader on multiple project teams across drug modalities (e.g., biologics, gene therapies) and therapeutic indications
• Early Development Team leader for a cross functional product team that drives nonclinical development and clinical development of pipeline molecules
• Interact with cross functional matrix team personnel within BioMarin and contribute to strategic and scientific planning and execution
• Accountable for immunogenicity assessment, monitoring and mitigation strategy for candidate molecule
• Author Immunogenicity sections of regulatory submissions, such as clinical study reports, investigator brochures, integrated immunogenicity reports, and BLA/MAA dossiers, etc.
• Interact with external collaborators, key opinion leaders, and regulators
• Author immunogenicity-focused publications and present findings at conferences and other public forums
• Represent Clinical Immunology on due diligence teams upon management request

EXPERIENCE:

• Required: PhD or equivalent relevant experience plus 8-10+ years industry experience
• Required: Cross-functional team leadership experience
• Required: Strong written and oral communication skills
• Preferred: Experience with immunogenicity of biologics and gene therapies
• Preferred: Expertise or familiarity with the complement pathway, particularly the impact of oligonucleotide therapies or gene therapies on complement activation, predictors of complement mediated toxicity in non-clinical models and in the clinic, understanding of downstream clinical effects and mitigation strategies
• Preferred: Strong analytical skills and proficiency at data analysis and interpretation
• 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

EDUCATION

• PhD or equivalent relevant experience plus 10+ years industry experience (Director Level)
• PhD or equivalent relevant experience plus 8+ years of industry experience (Associated Director Level)

Workstyle

        -  A hybrid workstyle requires a twice weekly onsite presence in San Rafael, CA (94901)
 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.