Bioanalysis and Biomarker Outsourcing Manager

Jobtailor; Massachusetts; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking an experienced biomarker program leader to develop and execute strategies for clinical studies in collaboration with Biomarker and Precision Medicine teams.

The role serves as the primary contact for outsourced biomarker activities, oversees vendor contracting, budgets, and timelines, and partners with regulatory, QA, and clinical operations to ensure regulatory compliance and data integrity across programs.

Qualifications

• Bachelor's degree in biology, biochemistry, pharmacology, or related field.
• 5+ years in pharma, biotech, or CRO with biomarker experience.
• Experience with regulated bioanalysis and external vendor management.

Responsibilities

• Develop and execute biomarker strategies for clinical studies.
• Serve as primary contact for externally conducted biomarker activities.
• Oversee vendor contracting, RFIs, RFPs, and governance.
• Ensure studies meet timelines, budgets, and quality standards.
• Interface with Regulatory Agencies and audit readiness.
• Collaborate with Central Labs, sample management, and Clinical Ops.

Skills

Vendor Management

Project Management

Biomarker Analysis

Bioanalytical Technologies

GxP Compliance

Budget Management

Contract Negotiation

Cross-functional Collaboration

Regulatory Interface

Problem-Solving

Education

Bachelor's degree in Biology/Biochemistry/Pharmacology or related field

Master's or Ph.D. preferred in Biology/Biochemistry/Pharmacology or related field

Tools

GxP Systems

Job description

• Develop and execute biomarker strategies and plans for clinical studies with Biomarker and Precision Medicine teams
• Serve as the primary point of contact for externally conducted biomarker activities
• Support budget forecasting, planning, tracking, and management
• Identify, evaluate, and onboard external vendors for specialized analytical services
• Provide scientific and technical oversight of external vendors
• Manage externalization and operationalization of biomarker and bioanalytical activities for preclinical and clinical drug development programs
• Ensure vendor studies meet agreed timelines, budgets, scientific objectives, and quality standards
• Oversee outsourced biomarker, pharmacokinetic (PK), and anti-drug antibody (ADA) bioanalytical activities
• Monitor assay development, validation, and sample analysis activities
• Support data reconciliation, review, and import processes
• Collaborate with Central Laboratories, sample management, and clinical operations teams on sample collection, handling, logistics, storage, and tracking
• Lead vendor contracting activities, including RFIs, RFPs, contract negotiations, and vendor governance
• Partner with Procurement, Legal, Finance, Quality Assurance, and other stakeholders
• Prepare for, support, and respond to audits
• Interface with Regulatory Agencies, external vendors, and internal stakeholders on inspections, inquiries, submissions, and documentation
• Build and maintain effective vendor relationships and ensure vendor performance meets project expectations

Requirements

• Bachelor's degree required in Biology, Biochemistry, Pharmacology, or a related scientific discipline
• Master's, or Ph.D. degree preferred in Biology, Biochemistry, Pharmacology, or a related scientific discipline
• Minimum of 5 years of experience in the pharmaceutical, biotechnology, or contract research organization (CRO) industry
• Experience in regulated bioanalysis, clinical biomarker development, translational medicine, or a related field is strongly preferred
• Demonstrated understanding of GxP requirements
• Experience working with outsourced laboratory or clinical research service providers
• Strong project management, organizational, and problem-solving skills
• Ability to manage multiple priorities in a fast-paced environment
• Expertise in preclinical and clinical bioanalysis and biomarker analysis, and clinical operations
• Strong understanding of biomarker and bioanalytical technologies
• Extensive experience in preclinical and clinical sample analysis
• Knowledge of GxP regulations and quality standards
• Ability to identify, troubleshoot, and resolve issues related to studies conducted at external vendors
• Excellent communication, collaboration, and stakeholder management skills
• Ability to work across multidisciplinary teams and interact with internal clients, external partners, and support functions
• Experience overseeing and managing external vendors and outsourced study activities is highly desirable
• Must be a resident of the United States or Puerto Rico

Core Competencies

Demonstrates expertise in biomarker strategies, clinical bioanalysis, and vendor management within the pharmaceutical and biotechnology sectors. Proficient in project management, regulatory compliance, and cross-functional collaboration to ensure successful execution of clinical studies.

Highest-signal resume keywords

• Biomarker Development
• Clinical Bioanalysis
• Project Management
• GxP Compliance
• Vendor Management

Hard Skills

• Biomarker Analysis
• Bioanalytical Technologies
• Sample Analysis
• Regulated Bioanalysis
• Translational Medicine
• Assay Development
• Data Reconciliation
• Budget Management
• Contract Negotiation
• Quality Standards

Soft Skills

• Problem-Solving
• Organizational Skills
• Communication Skills
• Collaboration Skills
• Stakeholder Management

Industry Keywords

• Pharmaceutical Industry
• Biotechnology
• Contract Research Organization
• Clinical Operations
• GxP Requirements