Clinical Biomarker Operations Manager US

Galapagos NV • Princeton, NJ

301d

About The Position

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class cell therapies in oncology. With capabilities from lab to patient, including a decentralized, CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. We are looking for a Clinical Biomarker Operations Manager, ideally based near Princeton NJ, US.

Requirements

• Life sciences degree (Master or PhD).
• Minimum 3 years professional experience in a clinical research setting, clinical or diagnostic laboratory or pharma or biotech R D environment. Experience with CAR-T is strongly preferred.
• Clinical development experience, with evidence of working in a clinical study team with exposure spanning initiation through study completion.
• Clinical or biological laboratory experience with knowledge of assay development and validation of one or more technologies is preferred (e.g. flow cytometry, multiplex immunoassays, quantification and sequencing of nucleic acids).
• Demonstrated project management experience (project management certification is desirable).
• Outsourcing and vendor management experience is desirable.
• Competent in contributing to and applying standard business procedures (e.g. standard operating procedures, ICH GCP, ethics, and compliance).
• Excellent communicator, with strong interpersonal skills, team building values and high ethical standards.
• Organized and analytically skilled, with a keen attention to details.
• Able to adapt quickly to changing priorities, with effective time management skills.
• Decisive and performance driven, while working collaboratively.
• Fluency in English both spoken and written.

Responsibilities

• Plan, coordinate and oversee operational activities required to manage the lifecycle of biomarker samples from clinical studies of cell therapies, from collection to reconciliation, shipment, processing, analysis, data transfer and sample storage and destruction.
• Support biomarker vendor selection and contracted scope, including contribution to requests for proposal, laboratory specification documents, vendor analytical plans and fit-for-method validation.
• Contribute to relevant clinical study documents and associated systems, including protocol and informed consent forms, eCRF, central lab specification document, sample collection and handling manuals, biomarker operational summary, service providers oversight plan, data transfer agreements, and TMF - define TMF.
• Oversee biomarker activities outsourced to contract research organizations and specialty laboratories to ensure efficient, on time and within budget delivery against contracted scope of work and in compliance with expected standards (e.g. GLP, GCP).
• Support regular updates to cross-functional stakeholders for each clinical study.
• Proactively identify opportunities to pioneer innovative methods and flexible solutions within day-to-day activities in support of the clinical biomarker strategy.

What This Job Offers

• Education Level: Master's degree