Manager, Biomarkers and Bioanalytical Operations
Job Location:
San Francisco, CA - USA
Monthly Salary:
Posted on:
Vacancies:
Job Summary
AboutThisRole:
The Biomarker and Bioanalytical Operations Study ManagerleadsPK 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 tothe Head of Biomarker and Bioanalytical Operations.
WhatYoullDo
Serve as the primary Biomarker and Bioanalytical Operations lead for internal teams and external partners across Phase 14 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 managementexpertiseto Study Management Teams (SMTs) and Biomarker Sub-Teams (BMSTs)
Ensure compliant high-qualitybiomarker and bioanalytical samplecollection 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-specificbiomarker and bioanalytical samplecollection handling analysis transport and storage strategies
Partner cross-functionally (Clinical Biomarker Clinical Pharmacology Clinical Operations Data Management Business Operations& Contracts Partner) to enable efficient executionof the study
Define data collection transfer and reconciliation requirements with data management bioanalytical leads and vendors
Identifyoperational risks implement mitigation plans and support interim and final biomarkerand bioanalyticalreporting
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. Yourexpertisein 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-IVclinical 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 testingrequirementsand timelines
Experience reviewing clinical protocolsICFs SOWand contracts
Experience obtaining contracts and an understanding of Master Agreements and associated contracts
Experience working within GCP GLP & GCLP guidelines
Must bevery organizedandhave the ability tomanage 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 toidentifyingand managing operational risks
Strong organizational and prioritization skills
Continuous improvement mindset with a focus onoptimizingprocesses and efficiency
This role involves minimal travel typically under 10%.
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 $10000 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 onto 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.
Required Experience:
Manager
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
