Associate Director, Clinical Biomarker Ops — Global Impact

Johnson & Johnson Innovative Medicine

Spring House (PA)

On-site

USD 139,000 - 238,000

Full time

2 days ago

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Benefits offered by this job

Annual bonus

Employee benefits (medical, dental, 3)

Vacation and sick time, holidays

Job summary

Johnson & Johnson Innovative Medicine in Spring House, PA (with positions also in La Jolla and Cambridge) seeks an Associate Director to lead biomarker operations across late-stage immunology programs. You will translate biomarker strategy into operational plans, manage biospecimens, ensure assay readiness, and coordinate with cross-functional teams to meet program milestones.

The role requires extensive experience in clinical biomarker operations, strong leadership, and deep knowledge of

Qualifications

Advanced degree in life sciences preferred; strong biomarker operations experience.
8+ years in pharma/biotech biomarker or translational science operations.
Experience leading global, multi‑vendor studies.
Knowledge of ICH GCP, GLP, data privacy, and regulatory expectations.

Responsibilities

Lead the operational planning and execution of clinical biomarker strategies across multiple complex studies or development programs.
Develop and maintain integrated biomarker operational plans, timelines, budget tracking, risk assessments, quality metrics, and resource forecasts from study start‑up through closeout.
Ensure end‑to‑end oversight of biospecimen collection, processing, shipment, storage, reconciliation, testing, and final disposition in accordance with protocols, informed consent, laboratory manuals, and applicable requirements.
Provide biomarker operations input to clinical protocols, informed consent forms, laboratory manuals, sample management plans, investigator materials, data transfer specifications, and other study documents.
Lead central and specialty laboratory strategy, including vendor evaluation, selection, qualification, contracting, onboarding, performance oversight, issue resolution, and closeout.
Partner with scientific leads to operationalize fit-for-purpose biomarker assays and ensure assay readiness, testing capacity, sample availability, and data delivery align with program milestones.