Onsite
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.
What You’ll Do:
· 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.
Who You Are:
You are a dynamic and innovative scientist with a passion for biomarker research. Your strong communication skills enable you to articulate complex scientific concepts clearly, and you thrive in collaborative environments. You are adept at independent problem-solving and are driven by a desire to contribute to advancements in clinical trials and
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.
Additional Information
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:
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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