Associate Director, Clinical Biomarkers Lead
Biogen
August 31, 2026
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
What You’ll Do
- 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 part of cross-functional program teams.
- Provide guidance and mentorship for biomarker strategy development and implementation.
- Coordinate and align biomarker activities with stakeholders across research, clinical development, regulatory, medical affairs, and commercial.
- Identify academic partners and maintain sponsored research agreements to accelerate biomarker goals.
- Matrix manage biomarker assay development scientists and oversee/manage multiple outsourced projects with CROs, technology partners, and academics.
- Plan and execute clinical trials; author and/or provide senior review of clinical protocols and regulatory/medical affairs documents/filings.
- Collaborate with immunology research, translational immunology, clinical research, biometrics, clinical pharmacology, and others to execute translational studies and interpret datasets.
- Engage regulators and industry professionals via conferences, workshops, consortia, and publications.
Required Skills
- PhD with 10+ years industry experience.
- 4+ years leading/implementing clinical biomarker strategies in immune-mediated diseases, including late stage/pivotal studies.
- Exceptional communication skills; ability to tailor biomarker data/presentations to different audiences.
- Demonstrated leadership in biomarker sciences (manuscripts, regulatory documents, regulator interactions).
- Strong understanding of clinical development and life cycle management.
- Proficiency in cytometry and immunoassay technologies, including clinical implementation strengths/limitations.
- Ability to rapidly learn relevant biology, pathways, MOA, and disease indications.
- Proven scientific leadership and matrix management of cross-functional teams.
- Ability to prioritize and deploy resources to meet key goals and timelines.
Benefits (if applicable)
- Medical, Dental, Vision, & Life insurances; fitness/wellness programs; short- and long-term disability; paid vacation and end-of-year shutdown; holidays; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- 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 part of cross-functional program teams.
- Provide guidance and mentorship for biomarker strategy development and implementation.
- Coordinate and align biomarker activities with stakeholders across research, clinical development, regulatory, medical affairs, and commercial.
- Identify academic partners and maintain sponsored research agreements to accelerate biomarker goals.
- Matrix manage biomarker assay development scientists and oversee/manage multiple outsourced projects with CROs, technology partners, and academics.
- Plan and execute clinical trials; author and/or provide senior review of clinical protocols and regulatory/medical affairs documents/filings.
- Collaborate with immunology research, translational immunology, clinical research, biometrics, clinical pharmacology, and others to execute translational studies and interpret datasets.
- Engage regulators and industry professionals via conferences, workshops, consortia, and publications.
Required Skills
- PhD with 10+ years industry experience.
- 4+ years leading/implementing clinical biomarker strategies in immune-mediated diseases, including late stage/pivotal studies.
- Exceptional communication skills; ability to tailor biomarker data/presentations to different audiences.
- Demonstrated leadership in biomarker sciences (manuscripts, regulatory documents, regulator interactions).
- Strong understanding of clinical development and life cycle management.
- Proficiency in cytometry and immunoassay technologies, including clinical implementation strengths/limitations.
- Ability to rapidly learn relevant biology, pathways, MOA, and disease indications.
- Proven scientific leadership and matrix management of cross-functional teams.
- Ability to prioritize and deploy resources to meet key goals and timelines.
Benefits (if applicable)
- Medical, Dental, Vision, & Life insurances; fitness/wellness programs; short- and long-term disability; paid vacation and end-of-year shutdown; holidays; sick time; paid maternity/parental leave; 401(k) with match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.