Principal Scientist, Clinical Biomarkers
Biogen
10 days ago
Remote friendly (San Francisco, CA)
United States
Clinical Research and Development
What You’ll Do
- Develop and implement comprehensive biomarker strategy for one or more clinical studies; provide strategic oversight to study-related documents.
- Drive analysis and interpretation of biomarker data to generate mechanistic insights supporting program development.
- Author and review biomarker sections for study protocols, SAPs, and regulatory documents (CSR, IB, BLA).
- Identify fit-for-purpose biomarker assays for PD, MoA, MoR, and disease monitoring biomarkers to inform clinical development.
- Collaborate with internal SMEs on vendor selection, qualification, and technology transfer; oversee outsourced projects with CROs/technology partners.
- Collaborate cross-functionally to execute translational studies and analyze/interpret biomarker datasets.
- Stay current with emerging biomarker technologies and trends in transplant and immune-mediated diseases.
- Contribute to decision-making via scientific communication and data-driven recommendations in a highly matrixed environment.
Who You Are / Required Skills
- PhD and/or postdoctoral training in immunology, molecular or cellular biology, translational sciences, or related discipline.
- 5+ years of industry experience developing and implementing biomarker strategies for clinical programs.
- Extensive experience with biomarker assays, including assay validation principles and clinical sample workflows.
- Strong written and verbal communication skills.
- Ability to operate independently in a highly matrixed environment and provide scientific oversight of external partners.
Preferred Skills
- Experience supporting clinical trials (regulatory filings and external communication documents).
- Experience in B cell immunology and/or nephrology and/or solid organ transplant programs.
Benefits (only as stated)
- Medical, Dental, Vision & Life insurances; Fitness & Wellness reimbursement; Short- and Long-Term Disability; paid vacation (minimum 15 days, plus end-of-year shutdown Dec 26–Dec 31); up to 12 paid holidays + 3 paid days for Personal Significance; 80 hours sick time; Paid Maternity and Parental Leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Develop and implement comprehensive biomarker strategy for one or more clinical studies; provide strategic oversight to study-related documents.
- Drive analysis and interpretation of biomarker data to generate mechanistic insights supporting program development.
- Author and review biomarker sections for study protocols, SAPs, and regulatory documents (CSR, IB, BLA).
- Identify fit-for-purpose biomarker assays for PD, MoA, MoR, and disease monitoring biomarkers to inform clinical development.
- Collaborate with internal SMEs on vendor selection, qualification, and technology transfer; oversee outsourced projects with CROs/technology partners.
- Collaborate cross-functionally to execute translational studies and analyze/interpret biomarker datasets.
- Stay current with emerging biomarker technologies and trends in transplant and immune-mediated diseases.
- Contribute to decision-making via scientific communication and data-driven recommendations in a highly matrixed environment.
Who You Are / Required Skills
- PhD and/or postdoctoral training in immunology, molecular or cellular biology, translational sciences, or related discipline.
- 5+ years of industry experience developing and implementing biomarker strategies for clinical programs.
- Extensive experience with biomarker assays, including assay validation principles and clinical sample workflows.
- Strong written and verbal communication skills.
- Ability to operate independently in a highly matrixed environment and provide scientific oversight of external partners.
Preferred Skills
- Experience supporting clinical trials (regulatory filings and external communication documents).
- Experience in B cell immunology and/or nephrology and/or solid organ transplant programs.
Benefits (only as stated)
- Medical, Dental, Vision & Life insurances; Fitness & Wellness reimbursement; Short- and Long-Term Disability; paid vacation (minimum 15 days, plus end-of-year shutdown Dec 26–Dec 31); up to 12 paid holidays + 3 paid days for Personal Significance; 80 hours sick time; Paid Maternity and Parental Leave; 401(k) with company match; employee stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.