Clinical Biomarker Operations and Biobank Lead US

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 and Biobank Lead, ideally based near Princeton NJ, US.

Scope of the job

This role centers on managing and maintaining oversight of the clinical sample life cycle, encompassing the strategic implementation and execution of operational biomarker, pharmacokinetic (PK) and pharmacodynamic (PD) strategies across clinical development programs and studies. It also involves active participation in the development, implementation and execution of the clinical biobank strategy to support the GLPG Biobank Governance Infrastructure. This position requires close collaboration with translational scientists and cross-functional partners, including clinical development leaders and teams, clinical study team members, data management leaders, procurement specialists, manufacturing operations and process development scientists. Additionally, this role emphasizes building strong partnerships with specialty laboratories, biorepositories/biobanks, and data analytics vendors.

Your role

• Plan, coordinate and oversee operational activities required to manage the life cycle of biomarker, PK and PD samples collected from our active cell therapy clinical studies at any stage, specifically focusing on collection to reconciliation, shipment, processing, analysis, data transfer and sample storage (including long term 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-purpose 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.

• Oversee biomarker, PK and PD activities outsourced to CROs 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.

• Manage and maintain oversight of the biorepositories/biobanks clinical sample inventory within the GLPG biospecimen information management system (BIMS), including the clinical sample life-cycle oversight (received, logged, stored, tracked, dispatched, returned/disposed).

• BIMs study set-up and sample data information management activities. 

• Collaborate with vendor biobanks to forecast, plan the clinical samples to be stored including contract/SOW, data transfer agreement (DTA) set-up, invoice and budget management.

• Collaborate with the vendors and stakeholders on clinical samples reception discrepancy resolutions.

• Manage and coordinate stakeholder clinical sample requests (use, storage and destruction).

• Organize and lead biobank advisory team meetings to address stakeholder sample requests facilitating the outcome including ICF review for use and storage.

• Collaborate with stakeholders to coordinate the clinical sample shipments to the vendor biobanks or from the vendor biobanks to the bioanalytical laboratories.

• Contribute operational expertise to identify opportunities to pioneer innovative and flexible solutions within day-to-day activities in support of the clinical biomarker operations and biobank strategy.

Who are you?

• Life sciences degree (Master or PhD).

• Minimum 5 years professional experience in a clinical research setting, clinical/diagnostic laboratory or pharma/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.

• Demonstrated experience in managing clinical biobank resources for research and clinical applications, including governance and compliance.

• 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.

What’s in it for you?

At Galapagos, we prioritize your continuous growth and development, fostering a culture of empowerment. Our employees are the driving force behind our mission to lead pharmaceutical research and innovation.

Base compensation for this position ranges from $135,750 to $226,250. Actual base compensation will be determined based on a variety of factors including experience, qualification, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time.

In addition, this position is eligible for participation in both Galapagos’ performance bonus plan and long-term incentive program. We offer comprehensive and generous benefits and program to help our colleagues lead healthy lives and to support important moments in life.

Galapagos is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job. 

We are Galapagos: together we can make it happen…!