Job Title: Director, Clinical Biomarkers Lab Head – Precision Medicine
Location: Hyderabad, India
Company: Amgen
Employment Type: Full-Time
Experience Required: 12+ years postdoctoral, clinical, or industry pathology experience
Amgen is a global biotechnology leader committed to developing innovative therapies that transform patient outcomes. With operations spanning across multiple countries and serving over 10 million patients worldwide, Amgen combines scientific innovation, operational excellence, and patient-focused strategies to deliver breakthrough treatments.
As part of the Precision Medicine (PMED) function, the Clinical Biomarkers Lab Head plays a pivotal role in biomarker and diagnostics strategy, supporting drug development programs with cutting-edge laboratory capabilities.
The Director, Clinical Biomarkers Lab Head will serve as the technical director and primary pathologist for a clinical testing laboratory encompassing immunohistochemistry (IHC), genomics (NGS/qPCR), and immunoassays (ELISA/MSD). This role is accountable for scientific strategy, operational efficiency, compliance, and the integrity of clinical sample testing. The position reports to US-based PMED management and partners with cross-functional teams to implement biomarker and diagnostic assay development.
Lead the establishment and operation of a GCLP-compliant clinical testing laboratory with IHC, genomics, and immunoassay capabilities.
Drive fit-for-purpose design, analytical validation, QC/QA monitoring, and timely revalidation/change control of biomarker assays.
Collaborate with computational imaging teams to develop digital pathology and AI algorithms for IHC and H&E-stained slides across therapeutic areas.
Provide expertise in human disease pathology and experimental pathology to interpret tissue-based assays.
Oversee laboratory performance metrics, including turnaround time (TAT), throughput, first-pass yield, capacity planning, and business continuity.
Ensure compliance with GCLP, data integrity guidelines, audit readiness, and implementation of corrective/preventive actions.
Mentor, train, and assess competency of laboratory personnel while promoting a culture of scientific excellence and safety.
Collaborate with stakeholders to integrate biomarker and diagnostics assay strategies into clinical programs.
MD or DVM pathologist with 12+ years of postdoctoral, clinical, or industry pathology experience.
Proven experience leading or working in GCLP-compliant laboratories.
Strong expertise in tissue-based analysis including IHC, in situ hybridization, fluorescence applications, and laser capture microdissection.
Knowledge of immunoassays and genomics assays including NGS/qPCR platforms.
Demonstrated leadership and mentoring experience in scientific teams.
Excellent verbal, written, and presentation skills for global collaboration.
Ability to work independently while driving cross-functional projects.
PhD in addition to professional degree.
Board certification in the United States (desirable but not required).
Familiarity with ISO 15189, 21 CFR Part 11/Annex 11, and digital pathology validation.
Expertise with image analysis software and algorithm design.
Strong track record in molecular pathology and publications.
High level of business acumen and strategic thinking.
Opportunity to lead a high-impact biomarker laboratory supporting global precision medicine programs.
Collaborate with world-class teams and cross-functional experts in drug development.
Competitive total rewards package, including health, financial, and retirement benefits.
Flexible work arrangements with focus on professional growth, mentorship, and innovation.
Award-winning time-off and wellness programs.
Amgen is an Equal Opportunity Employer, committed to inclusion and diversity. Individuals with disabilities are provided reasonable accommodations to participate in the application or interview process.
Apply now to take your career to the next level as Director, Clinical Biomarkers Lab Head and contribute to transformative therapies in precision medicine.
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