Develop and implement comprehensive biomarker strategy for one or more clinical studies and provide strategic oversight to study-related documents.
Drive the generation of analysis and interpretation of biomarker data in clinical studies, generating mechanistic insights to support 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 of biomarker assays, and oversee multiple outsourced projects with contract research laboratories and technology partners.
Collaborate with Discovery Biomarkers, Clinical Development, Biometrics, Clinical Pharmacology, and other cross-functional teams to execute translational studies and analyze and interpret biomarker datasets.
Stay current with emerging biomarker technologies and trends in transplant and immune-mediated diseases.
Work effectively in a highly matrixed environment and contribute to decision-making through scientific communication, data-driven recommendations, and stakeholder engagement.
Requirements
regulatory processes. Your ability to stay informed about the latest biomarker technologies and trends ensures that you remain at the forefront of your field.
Required Skills:
PhD and/or postdoctoral training in immunology, molecular or cellular biology, translational sciences, or a related discipline.
5+ years of relevant industry experience with direct involvement in developing and implementing biomarker strategies for clinical programs.
Extensive experience with biomarker assays, including working knowledge of assay validation principles and clinical sample collection, handling, and analysis workflows.
Strong written and verbal communication skills.
Ability to operate effectively and independently in a highly matrixed environment, collaborating across functions and providing scientific oversight of external partners.
Preferred Skills:
Experience supporting clinical trials, including contributing to regulatory filings and external communication documents.
Experience in B cell immunology and/or clinical programs in nephrology and/or solid organ transplant.
Job Level: Management
Additional Information
The base compensation range for this role is: $140,000.00-$187,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to:
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calend
Benefits
Dental insuranceVision insurance401(k)Paid time offEquity / stock optionsPerformance bonusParental leave
Additional Information
About This Role:
As a Principal Scientist in Clinical Biomarkers, you will play a pivotal role in the design, execution, and interpretation of biomarker activities across our clinical studies. Positioned within the West Coast Hub (WCH) team, you will work closely with Discovery Biomarkers, Clinical Development, Clinical Pharmacology, Biostatistics, Regulatory, and external CROs to ensure the timely delivery of high-quality biomarker data. This role is crucial in aligning study-level biomarker activities with program biomarker strategy, generating data that informs clinical development, regulatory submissions, and key program decisions. Your work will advance our understanding of solid organ transplants and enhance clinical trial outcomes. Within our highly matrixed environment, you will drive scientific and technical innovation, significantly contributing to the overall success of our projects.
Biogen · San Francisco, CA