Associate Director, Clinical Biomarkers Lead

About This Role

We are seeking a highly motivated and experienced Associate Director, Clinical Biomarkers Lead to support clinical biomarker development activities for our portfolio of immunology and neuromuscular clinical programs. As the Associate Director, Clinical Biomarkers Lead, you will be responsible for the oversight of the development, implementation, and execution of biomarker strategies for programs across the Biogen portfolio. Reporting directly to the West Coast Hub Head of Clinical Biomarkers and as a key member of the development team, you will support end-to-end biomarker development for our novel therapeutic candidates.

• Develop and implement comprehensive biomarker strategies for therapeutic programs in clinical development, including pivotal/phase 3 programs
• Drive the generation, analysis, and interpretation of biomarker data in clinical studies as a key member of cross-functional program teams
• Provide guidance and mentorship to members of the group focused on biomarker strategy development and implementation
• Liaise with relevant stakeholders in research, clinical development, regulatory, medical affairs and commercial to coordinate and align biomarker activities in support of immunology therapeutic programs
• Build strong partnerships with external collaborators by identifying potential academic partners to accelerate achievement of biomarker goals and maintain existing sponsored research agreements
• Matrix manage biomarker assay development scientists and oversee/manage multiple outsourced projects with contract research laboratories, technology partners, and academics
• Support the planning and execution of clinical trials;
  Author and/or provide senior review of clinical protocols, medical affairs, and regulatory documents/filings
• Collaborate with immunology research, translational immunology, clinical research, biometrics, clinical pharmacology, and others to execute translational studies and analyze and interpret biomarker datasets
• Actively engage with regulators and industry professionals via conference presentations, workshops, consortia, and publications to influence best practices for biomarker development and clinical implementation

You are an experienced biomarker leader with a proven track record of developing and delivering biomarker strategies across all stages of drug development. You will have excellent strategic thinking, communication, and collaboration skills while being able to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress therapeutic programs in clinical development.

• PhD with 10+ years industry experience
• 4+ years direct experience leading/implementing clinical biomarker strategies in immune mediated diseases including for late stage/pivotal studies
• Exceptional communication skills with proven ability to deliver clear, concise biomarker focused data and presentations tailored to different audiences including commercial colleagues
• Demonstrated leadership in biomarker sciences including authoring manuscripts, regulatory documents, and direct interactions with regulators
• Strong understanding of the clinical development and life cycle management process
• Well versed in relevant technologies, particularly cytometry and immunoassay technologies with strong understanding of inherent advantages and limitations specifically with respect to clinical implementation
• Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, and disease indication(s)
• Proven scientific leadership and matrix management of high performing individuals and cross functional teams required
• Ability to prioritize and deploy resources effectively and…