(Senior) Manager, Biomarker Operations

Overview

Cambridge, US; Gaithersburg, US; New Jersey, US | full time | Job ID: 9866

Summary: We are seeking an experienced (Senior) Manager to lead biomarker operations for global Phase I-IV clinical trials. This role ensures seamless sample management, compliance with clinical protocols, vendor oversight, and delivery of high-quality outcomes in alignment with ICH/GCP regulations. The (Senior) Manager will optimize biomarker logistics, manage metrics and budgets, and drive cross-functional collaboration. With a strong background in life sciences and clinical operations, you will contribute to advancing innovative therapies in oncology and infectious diseases.

Responsibilities

• Execution of the biomarker strategy, including biospecimens collected for central assessment of Pharmacokinetics, Immunogenicity, Biomarkers and Safety and for Companion Diagnostics development.
• Planning, coordinating, and overseeing all operational activities required to manage the lifecycle of biospecimens in global Phase I-IV clinical trials.
• Ensure biospecimen collection, tracking, and storage in compliance with the Clinical Trial Protocol and Patient Informed Consent.
• Management of cross-functional integration and execution of operational biomarker elements.
• Ensuring biomarker operational deliverables in time and quality (including ICH/GCP regulations).
• Building efficient biospecimen logistics from study set-up until data delivery and study close-out.
• Establishment and ensuring accurate tracking and reporting of biospecimens and related data metrics.
• Work with internal functions on the selection and contracting process for biospecimen processing, analysis and central lab vendors.
• Support relevant functions for the qualification of the vendors.
• Management of day-to-day operational routine activities delegated to bioanalytical and processing lab vendors including vendor management and oversight, performance management, escalation of issues.
• Provide sample forecasts for resource and cost planning.
• Provide and track external costs for budgeting purposes.
• Oversight of biospecimens in clinical trials with high complexity and across continents.
• Be accountable for the Biomarker Operations deliverables of assigned programs, study team goals and milestones.
• Contribute to or author relevant biomarker documents such as Biomarker Manuals, Lab Manuals.
• Partner with Translational Science, Clinical Operations, or other departments in identifying gaps and needs for process improvements.
• Support as requested in the implementation of new processes or process improvements to optimize operational efficiency incl. preparation and revision of SOPs and guidance documents.
• Act as liaison point for internal labs to ensure efficient communication and information flow.
• Mentoring junior team members or newcomers.

Qualifications

• Education: Natural/ life sciences or medical background (university degree or experience in a medical profession such as Nurse or Medical Technical Assistant or Laboratory Technical Assistant).
• Experience: At least 3 years of experience (Manager) or at least 5 years of experience (Senior Manager) in clinical operations or central laboratory operations including clinical sample tracking/management (e.g., Biomarker, PK/PD) and/or sample reconciliation activities.
• Senior Manager candidates should demonstrate a proven ability to work collaboratively across functions, contributing to the development of biomarker strategies and processes while incorporating operational feasibility expertise.
• Proven knowledge of analytical methods used in therapeutic areas like Oncology, Immuno-oncology or Infectious Diseases.
• Proven track records of independent contributions to global clinical studies (e.g., in CRO, biotech/pharmaceutical companies and/or central labs).

Compensation & Benefits

Expected Pay Range: $113,600 to $209,400/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance). Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

• BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce.
• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

…and more! More details to be shared.

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge’s thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider HireRight. You will be informed accordingly by your BioNTech-Recruiter.