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Director, Clinical Immunology

Employer
BioMarin Pharmaceutical Inc.
Location
San Rafael, California
Start date
Dec 7, 2023

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Job Details

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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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