Associate Director, Late Stage Clinical Fluid Biomarkers, Immunology

Role Summary

The Fluid Biomarker group seeks an experienced leader to implement biomarker strategies supporting clinical therapeutic development in the Immunology portfolio. The role oversees development and execution of biomarker strategies across all stages of drug development, with emphasis on Phase 2 and beyond. The successful candidate will have immunology expertise and proven leadership in delivering biomarker programs, with strong strategic thinking, communication, and collaboration skills.

Responsibilities

• In collaboration with other members of the biomarker team, develop and implement biomarker strategies for preclinical and clinical development programs. Provide guidance and direction to fluid members of the group focused on biomarker strategy development and implementation.
• Liaise with relevant stakeholders in clinical, regulatory, and commercial to coordinate and align biomarker activities in support of clinical development and marketed programs in the Immunology franchise
• Build strong partnerships with external collaborators by identifying potential academic partners to accelerate achievement of biomarker goals and maintaining existing SRAs
• Matrix manage 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 and regulatory filings; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings and regulatory engagements
• Actively engage with regulators and industry professionals via conference presentations, workshops, focus groups and publications to influence best practices for biomarker development and clinical implementation

Qualifications

• PhD in related science field with 8+ years of experience in industry
• Proven scientific leadership and matrix management of high performing individuals and cross functional teams required
• Deep expertise in executing clinical biomarker strategies across a range of modalities (i.e. small molecule, biologics, anti-sense), with an emphasis on pivotal and/or post-marketing studies
• Strong background in immunology, immune cell biology (innate and adaptive immunity) and cellular signaling with emphasis on expertise in biomarker development and implementation to support immunology clinical development programs
• Exceptional verbal and written communication skills; proven ability able 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
• Ability to quickly absorb new information and develop an understanding of the relevant biology, pathway, MOA, disease indication(s)
• Demonstrated ability to influence without authority and efficiently drive alignment amongst multiple stakeholders to efficiently progress programs/projects
• Well versed in relevant technologies such as flow cytometry, mass cytometry (CyTOF), ELISpot, Luminex, single-cell RNA sequencing, TCR/BCR repertoire sequencing, with a strong understanding of the inherent advantages and limitations—specifically with respect to clinical implementation and interpretation. Ability to prioritize and deploy resources effectively and appropriately to meet key goals and timelines