Director, Clinical Biomarker Operations- Translational Sciences- Immunology
About The Position
This position resides within the Immunology Translational Sciences group and requires a highly motivated, skilled and proactive candidate to drive the translational research for innovative therapies across immune-mediated diseases. The Director, Clinical Biomarker Operations will lead the Immunology biomarker operations function within Translational Science. This role is accountable for establishing and executing a centralized, scalable, and high‑quality clinical biomarker operations model to support Immunology clinical programs across early and late development. The successful candidate will be single point of accountability for clinical biomarker operational execution in Immunology, shape the overall strategy for clinical biomarker execution, and lead a team of biomarker operations professionals. The role will bridge science and operations through cross-functional partnerships, strategic project planning, and driving key initiatives and decisions on clinical biomarker execution.
Requirements
- Advanced degree in Life Sciences, Biomedical Sciences, Medicine, or related discipline.
- 8+ years of experience in clinical biomarker operations within pharmaceutical or biotechnology R&D, with 3+ years in a leadership role.
- Demonstrated people leadership skills in a matrixed environment and cross‑functional influencing experience.
- Extensive hands-on experience with compliance/oversight of operationalizing clinical biomarker assays, contracting service laboratories, and biosample tracking systems.
- Proven ability to build and scale SOP‑driven operational models and to effectively prioritize, organize, and lead cross-functional projects.
- Strong knowledge and understanding of clinical research, ICH GCP, GLP; Familiarity with global health authority interactions.
- Proven track record of evaluating, selecting, and developing strategic partnerships with vendors and external collaborators.
- Experience supporting Immunology clinical programs strongly preferred.
- Direct people management experience strongly preferred.
Responsibilities
- Define and drive the biomarker operations strategy for Immunology Translational Science, including definition of roles, responsibilities, and ways of working.
- Establish, implement, and maintain standardized biomarker operations processes and SOPs to ensure consistent execution across programs.
- Provide operational leadership across early and late‑stage Immunology clinical programs, overseeing biomarker plans, timelines, budgets, risks, and quality metrics.
- Provide expert biomarker and diagnostic development input into required clinical documents such as protocols, ICF, IB, and lab manuals.
- Ensure end‑to‑end execution of biospecimen collection, testing, and data delivery to meet clinical development needs.
- Ensure compliance with global regulatory requirements, ICH GCP, GLP, and quality standards for biomarker and diagnostic deliverables.
- Shape and lead biomarker vendor strategy, setup, and lifecycle management for Immunology studies, oversee vendor selection and performance management in partnership with Procurement and scientific stakeholders.
- Drive continuous improvement in efficiency, quality, and scalability of clinical biomarker operations.
- Identify and foster critical collaborations with strategic partners, vendors, and external collaborators; Evaluate, select, and develop strategic partnerships to position the organization for future business needs.
- Develop and maintain strong relationships with internal and external stakeholders; Communicate progress, challenges, and changes that may impact timelines to leadership.
- Serve as the single point of accountability for biomarker operational execution within Immunology Translational Science.
- Lead, mentor, and develop the Immunology biomarker operations team, setting clear expectations and fostering a high‑performing culture.
- Establish internal working groups to develop best practices and operational solutions.
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Company’s long-term incentive program.
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
