About This Role:
The Biomarker and Bioanalytical Operations Study Manager leads PK, ADA, and biomarker execution across clinical studies, partnering with study teams and CROs to deliver high-quality data on time. This role is critical to achieving key study endpoints and advancing programs through drug development and reports to the Head of Biomarker and Bioanalytical Operations.
What You’ll Do
Serve as the primary Biomarker and Bioanalytical Operations lead for internal teams and external partners across Phase 1–4 studies
Lead end-to-end operational execution of biomarker and bioanalytical activities, including sample collection, processing, shipment, testing, storage, and data delivery
Implement clinical biomarker and bioanalytical strategies for early- and late-stage programs
Provide operational and sample management expertise to Study Management Teams (SMTs) and Biomarker Sub-Teams (BMSTs)
Ensure compliant, high-quality biomarker and bioanalytical sample collection aligned with protocols, ICFs, ethical standards, and regulations
Oversee CROs, central labs, and specialty vendors; manage performance, timelines, quality, contracts, and deliverables
Review and contribute operational input to protocols, CRFs, ICFs, proposals, budgets, study plans, and contracts
Develop study-specific biomarker and bioanalytical sample collection, handling, analysis, transport, and storage strategies
Partner cross-functionally (Clinical Biomarker, Clinical Pharmacology, Clinical Operations, Data Management, Business Operations & Contracts Partner) to enable efficient execution of the study
Define data collection, transfer, and reconciliation requirements with data management, bioanalytical leads, and vendors
Identify operational risks, implement mitigation plans, and support interim and final biomarker and bioanalytical reporting
Lead operational meetings, RFPs, vendor selection, and process improvement initiatives
Maintain biomarker operations systems and documentation; represent on cross-functional teams
Operate independently with general supervision; support investigator meetings and internal/external presentations as needed
Who You Are
You excel in fast-paced clinical development environments dedicated to advancing new therapies to patients. Your expertise in scientific operations, GCLP, and CRO management enables effective collaboration across internal teams and external laboratory partners.
Required Skills
Minimum Education & Experience
Advanced degree (PharmD or PhD) with 2+ years of relevant industry experience; MA or MS with 6+ years; or BA/BS or RN with 8+ years of comparable clinical, life sciences, or similar industry experience.
Good knowledge of phase I-IV clinical study operations as it pertains to specialty testing (PK, ADA, Biomarkers)
Experience working with contracted central labs and biomarker/bioanalytical testing labs including sample management, data management, testing requirements and timelines
Experience reviewing clinical protocols, ICFs, SOW, and contracts
Experience obtaining contracts and an understanding of Master Agreements and associated contracts
Experience working within GCP, GLP, & GCLP guidelines
Must be very organized and have the ability to manage multiple projects at a time
Preferred Skills
Demonstrated ownership of operational execution and accountability for outcomes
Proven ability to manage CROs and external vendors effectively
Solid understanding of clinical trial conduct and the drug development process
Strong cross-functional collaboration and stakeholder partnership skills
Clear, confident verbal and written communication
Proactive approach to identifying and managing operational risks
Strong organizational and prioritization skills
Continuous improvement mindset with a focus on optimizing processes and efficiency
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 Biogen.
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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