About This Role
The Head of Biomarker Operations, West Coast Hub (WCH) is a strategic and operational leader responsible for driving the biomarker operations function across the WCH therapeutic portfolio. This role oversees a team of Biomarker Operations Study Managers and ensures the successful execution of biomarker and bioanalytical strategies that support clinical development from early to late-stage programs, including multiple registrational studies. Reporting directly to the Head of Biomarkers and Clinical Pharmacology, WCH, this role is a key interface with cross-functional stakeholders, including Clinical Biomarkers, Clinical Operations, Biometrics, Clinical Pharmacology, Regulatory, Quality and other internal and external partners. The successful candidate will bring deep operational expertise, scientific acumen, and leadership presence to ensure the delivery of high-quality biomarker and bioanalytical data that informs clinical development and regulatory strategy.
Key Responsibilities:
Build, lead, and mentor a high-performing team of Biomarker Operations Study Managers
Define and drive the biomarker operations strategy for the WCH programs, ensuring alignment with goals and priorities
Provide strategic input into biomarker and bioanalytical planning, execution, and resource allocation across multiple programs and studies
Serve as the primary liaison between biomarker operations and WCH Clinical Operations, Data Management, Quality, and other key cross-functional leaders
Champion integration of biomarker operations into clinical trial design and execution, ensuring seamless coordination across functions
Represent biomarker operations in key WCH forums, program teams, and strategic planning discussions
Establish and oversee best practices for biosample collection, processing, storage, and testing strategies that are tailored to protocol requirements
Ensure robust vendor oversight and management of central and specialty labs to meet quality and timeline expectations
Lead process improvement initiatives to enhance operational efficiency, data integrity, and compliance with GCP, GLP, and GCLP standards
Ensure timely delivery of high-quality biomarker and bioanalytical data for registrational studies, consistent with the sample collection and assay plans and clinical protocols, to support regulatory filings and approval
Partner with Quality and Compliance functions to uphold standards across biomarker operations, ensuring audit readiness and adherence to internal and external regulatory expectations
Ensure biomarker data is delivered in a format and quality suitable for regulatory submissions and scientific publications
Provide expert input into protocol development, informed consent forms (ICFs), and data management plans
Qualifications:
Bachelor’s degree in a biological science or related technical field with 15+ years experience or advanced degree with 12+ years experience
Extensive industry experience in clinical biomarker operations, biomarker/bioanalytical sciences, clinical operations, or related disciplines in the clinical trial setting
Proven leadership experience managing teams and driving strategic initiatives in matrixed, fast-paced clinical development environment
Deep understanding of clinical trial operations across all phases of development, biomarker strategy, and specialty lab testing (PK, ADA, exploratory biomarkers)
Experience with data integration and transfer processes between testing vendors and internal data systems
Expertise in biomarker and bioanalytical assay platforms (e.g. flow cytometry, immunoassays, genomics, etc)
Familiarity with contracting processes, including Master Service Agreements and Statement of Work development
Demonstrated success in cross-functional collaboration, vendor management, and GCP/GLP/GCLP compliance
Experience supporting biomarker and/or bioanalytical operations for registrational studies and regulatory filings
Exceptional organizational, communication, and stakeholder engagement skills
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:
- 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 calendar year
- Employee Resource Groups participation
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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
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