(Senior) Manager, Biomarker Operations

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 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

 

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 (eg, 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)

 

 

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.