Scientist 2, Clinical Immunology
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 Clinical Immunogenicity Group within BioMarin is seeking an immunologist with an interest to gain drug development experience. This position 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 interact and collaborate with diverse functional groups within Biomarin, including Research, Pharmacology/Toxicology, Clinical Pharmacology, BioAnalytical Sciences, Clinical Sciences, Pharmacovigilance, Biostatistics, Regulatory, and Medical Affairs. 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.
- 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 Clinical Immunology 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.
- 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
- Expert immunologist with experience in the field of immunogenicity assessment of biologic therapeutics
- PhD or equivalent relevant experience plus 2+ years industry experience
- Understanding of immunogenicity 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
- 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
- PhD or equivalent relevant experience plus 2-5 years industry experience
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
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.