Principal Scientist Biomarker Clinical Assay Lead – Translational

Principal Scientist Biomarker Clinical Assay Lead – Translational

Requirements

• PhD or PharmD with 4+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies) OR
• MS with 6+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies) OR
• BS with 8+ years of industry or clinical laboratory experience in Oncology biomarker assay development, assay validation, and implementation within clinical trials employing a broad range of platform technologies (e.g., NGS, IHC, PCR, FISH, flow cytometry, other cell based and circulating biomarker technologies)
• Extensive knowledge of clinical laboratory regulatory and compliance requirements (e.g., GCLP, CAP, CLIA) for fit for purpose biomarker assay oversight within oncology clinical trials.
• Strong verbal and written communication skills

Responsibilities

• Provide technical and operational expertise in biomarker bioanalytical assays to Study Teams to ensure high-quality clinical biomarker data delivery.
• Collaborate with Study Teams and Clinical Operations to ensure proper biomarker sample handling and processing procedures are outlined in the clinical trial Laboratory Manual.
• Lead novel assay development and timely availability of fit-for-purpose oncology clinical biomarker assays to clinical Study Teams.
• Address and resolve complex technical and logistical challenges at vendor sites.
• Critically evaluate complex data, identifying anomalies, trends, and guiding the team in interpreting data within a broader context.
• Serve as the primary point of contact for external commercial or academic clinical laboratories, overseeing agreements, work plans, budgets, invoices, assay transfers, assay validation, sample analyses, data transfers, and overall data quality.
• Lead and provide technical support for the selection, qualification, and periodic audits of CRO laboratories supporting clinical trial biomarker assays.
• Contribute to the selection and development of biomarker CRFs; lead the development of data transfer processes with internal and external biomarker laboratories and the internal data management team.
• Lead and contribute to the continuous improvement of best practice processes and templates. Spearhead and guide sub-teams or initiatives aimed at enhancing efficiency. Provide strategic direction for internal, cross-functional, and external continuous improvement efforts.
• Stay current with advances in biomarker assay technologies, clinical laboratory standards, regulatory guidelines (e.g., GLP, GCLP), and compliance requirements.
• Provide expertise and guidance to colleagues within the organization.

Preferred Qualifications

• Experience with clinical or companion diagnostics
• Extensive CRO management and outsourcing engagement experience
• Experience with Oncology specialty platforms, Molecular Oncology, or Hematopathology
• Clinical Lab Science (CLS) or American Society of Clinical Pathologist (ASCP) certification
• Strong track record of publications and/or conference presentations demonstrating recognized subject matter expertise in one or more of these areas: IHC, multiplex immunoassay technologies, and Molecular Oncology (NGS) assays
• Creativity and adaptability to explore new research methodologies, technologies, and approaches that enhance translational research outcomes.
• 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.
• Prior experience as a project leader or functional leader on interdisciplinary team is critical.
• Ability to work with radioisotopes with strict adherence to radiation safety protocols.
• Ability to successfully establish and manage external collaborations including CROs and academic and industrial partnerships.