(Senior) Manager, Biomarker Operations

BioNTech•Gaithersburg, MD

28d

About The Position

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

Requirements

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
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)

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 of 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

Benefits

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