Sr. Scientist, Translational Medicine
About The Position
As a Senior Scientist, Translational Medicine supports clinical biomarker strategy for our oncology pipeline. This is an operationally focused, hands-on role for a scientist who has already worked directly on oncology clinical studies and understands what it takes to get biomarker samples from protocol design through data delivery. The successful candidate will partner closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Data Management to ensure biomarker sample collection, central lab and CRO/vendor oversight, and analytical assay execution are planned and delivered to the highest scientific and quality standards across one or more oncology clinical programs. This role is best suited to a scientist with a strong foundation in clinical biomarker operations who is ready to grow into broader translational strategy leadership. The Senior Scientist will work under the guidance of the Translational Medicine Lead while independently owning day-to-day biomarker execution for assigned studies. As they gain experience, the role expands to include progressive ownership of biomarker strategy, as well as driving scientific data interpretation and actionable recommendations. The position will require an ability to work effectively in interdisciplinary team settings. The role requires an ability and willingness to work with radioactive isotopes.
Requirements
- Ph.D. in a relevant scientific discipline (e.g., oncology, molecular biology, immunology, cancer biology) with minimum of 2 years of direct experience supporting oncology clinical studies within a pharmaceutical, biotechnology, or CRO setting.
- Hands-on experience with clinical study protocol and ICF review, biomarker sample collection procedures, and end-to-end sample management (collection, tracking, shipment, storage, reconciliation).
- Demonstrated experience working cross-functionally with Clinical Operations, Clinical Science, Biostatistics, Data Management, and Regulatory/QA teams.
- Direct experience working with central laboratories and external CRO/testing laboratories, including vendor communication and issue resolution.
- Working familiarity with analytical assay validation/qualification principles for the following: IHC, immunoassay platforms, and sequencing-based (NGS/qPCR) technologies.
- Experience contributing to or supporting the selection, qualification, and oversight of external vendors.
- Strong organizational, project management, and communication skills; ability to manage multiple studies/priorities in a matrixed environment.
- Working knowledge of GCP, GCLP, and applicable regulatory requirements governing clinical biomarker sample handling and testing.
- Ability and willingness to work with radioactive isotopes.
Nice To Haves
- Experience working on clinical studies involving radiopharmaceutical therapy (RPT)/radioligand therapy (RLT) programs.
- Prior experience authoring or reviewing translational/biomarker sections of clinical protocols, laboratory manuals, or regulatory submissions.
- Familiarity with electronic data capture and sample tracking systems.
- Experience supporting assay transfer, cross-validation, or bridging studies between internal and external laboratories.
- Prior involvement in vendor audits or supplier quality assessments.
- Ability to work collaboratively with clinicians, researchers, bioinformaticians, and other stakeholders to integrate diverse perspectives and advance translational research goals.
- Excellent written and oral communication and presentation skills and ability to work in a fast-paced, dynamic, and collaborative environment.
- Strong interpersonal, organizational and communication skills.
- Ability to work with radioisotopes with strict adherence to radiation safety protocols.
Responsibilities
- Serve as the primary biomarker/translational medicine representative on clinical study teams for oncology trials.
- Support end-to-end management of biomarker sample logistics, chain-of-custody, inventory tracking, reconciliation, and deviation resolution in collaboration with Clinical Operations and clinical sites.
- Provide scientific review of biomarker components in protocols, ICFs, regulatory documents, laboratory manuals, and sample collection tables/kits to ensure biomarker objectives, sample types, collection procedures, and logistics are scientifically sound and operationally feasible in alignment with GCP/GCLP.
- Partner with Data Management and Biostatistics on eCRF/biomarker data specifications, data transfer agreements, and data reconciliation.
- Oversee assay selection, tech transfer, and cross-validation for exploratory and clinical endpoints (IHC, immunoassays, NGS, qPCR). Evaluate vendor assay readiness by reviewing validation plans, reports, and performance data to ensure fitness-for-purpose.
- Manage CROs, and specialty testing vendors from qualification and SOW/contract review to ongoing performance monitoring. Troubleshoot logistical/technical issues, oversee assay transfers, and act as the primary scientific point of contact.
- Collaborate with Translational Science and BMS teams on assay selection, cross-validation, and platform transfer for exploratory biomarker endpoints.
- Support development and maintenance of SOPs, best practices, and tracking tools for biomarker sample and vendor management.
- Communicate biomarker sample status, testing timelines, and data readiness to study teams and management; escalate risks proactively.
- Contribute to interpretation of biomarker data in the context of efficacy, safety, and patient selection to inform program decisions.
Benefits
- wellbeing support
- retirement and financial protection benefits
- insurance offerings (medical, dental, vision, life and disability)
- Flexible Time Off (FTO)
- 11 paid company holidays
- 160 hours of paid vacation annually
- 3 optional holidays
- paid sick leave
- up to two paid volunteer days per year
- summer hours flexibility
- leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs
- annual Global Shutdown between Christmas Day and New Year's Day
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
