Clinical Biomarkers Lead, Strategy & Execution

Biogen, Inc.; San Francisco (CA); On-site; USD 161,000 - 222,000; Full time

Benefits offered by this job

Medical, Dental, Vision, & Life ins.

Fitness & Wellness programs

401(k) with match

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director, Clinical Biomarkers Lead to oversee biomarker development strategies across immunology and neuromuscular programs. You will lead end-to-end biomarker efforts, overseeing client collaborations and cross-functional teams on West Coast initiatives.

The role requires a PhD with extensive biomarker leadership experience, strong communication, and the ability to influence across research, clinical, regulatory, and commercial groups.

Qualifications

• PhD with 10+ years of industry experience.
• 4+ years direct experience leading/implementing clinical biomarker strategies in immune mediated diseases including late-stage studies.
• Exceptional communication skills with ability to present biomarker data clearly to diverse audiences.
• Demonstrated leadership in biomarker sciences, including manuscripts, regulatory documents, and regulator interactions.
• Strong understanding of clinical development and lifecycle management.
• Well versed in cytometry and immunoassay technologies for clinical use.
• Ability to rapidly absorb new biology and disease indications.
• Proven scientific leadership and matrix management of cross-functional teams.
• Ability to prioritize and deploy resources to meet key milestones.

Responsibilities

• Develop and implement comprehensive biomarker strategies for clinical programs including pivotal/phase 3.
• Drive generation, analysis, and interpretation of biomarker data in clinical studies with cross-functional teams.
• Mentor group members on biomarker strategy development and implementation.
• Coordinate biomarker activities with research, clinical development, regulatory, medical affairs, and commercial teams.
• Build partnerships with academics and CROs to accelerate biomarker goals.
• Manage biomarker assay development scientists and outsourced projects with labs and partners.
• Support planning and execution of clinical trials; author/review protocols and regulatory documents.
• Collaborate on translational studies and analysis of biomarker datasets.
• Engage regulators and industry groups to influence biomarker practices.

Skills

Biomarker strategy leadership

Scientific leadership

Regulatory interactions

Education

PhD in relevant field

Tools

Cytometry

Immunoassays

Biomarker assays

Job description

Biogen is seeking an Associate Director, Clinical Biomarkers Lead to oversee biomarker development strategies across immunology and neuromuscular programs. You will lead end-to-end biomarker efforts, overseeing client collaborations and cross-functional teams on West Coast initiatives.

The role requires a PhD with extensive biomarker leadership experience, strong communication, and the ability to influence across research, clinical, regulatory, and commercial groups.