Senior Clinical Biomarker Lead - Oncology

Senior Clinical Biomarker Lead - Oncology Compensation Data

The base salary range for this position is $ to $ USD. The position may be eligible for a role specific discretionary bonus, relocation, and/or other compensation elements. We continuously review market data and may adjust salary ranges as needed in the future. Actual compensation will be based on job-related factors such as skills, experience, and qualifications, and other factors permitted by law.

For an overview of our benefits please .

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work‑life balance.

Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Through integrative leadership, the Senior Clinical Biomarker Lead will provide clinical development and biomarker strategies in early clinical development. In addition, this position will drive and support translational medicine and biomarker aspects in post‑PoC (Proof of Concept) projects including drug registration and Product Maintenance & Optimization (PMO) activities.

The Senior Clinical Biomarker Lead will enable the discovery, translation, fit‑for‑purpose assay validation, analysis and clinical qualification of biomarkers. This role will ensure appropriate and timely evaluation, interpretation and reporting of clinical biomarker data including presentation at relevant meetings/committees. As appropriate, the incumbent will initiate and lead exploratory non‑interventional human studies and assess novel biomarker methods and assays.

• Be a role model for integrative leadership in all aspects of clinical drug development (early and late‑stage).
• Ensures regulatory compliance with ICH GCP (or alike) of biomarker analysis in clinical studies to provide credible and reliable data and reported results, and to protect the rights, safety, wellbeing, and confidentiality (data integrity, protection and data privacy) of trial subjects.
• As Trial Biomarker Analyst (TBMA), executes the agreed biomarker strategy in conjunction with internal as well as external partners and interfaces.
• For Boehringer‑sponsored clinical trials, this includes operational aspects, e.g., the fit‑for‑purpose assay validation, implementation, monitoring, data transfer and reporting of biomarkers, as well as budgetary adherence.
• As Biomarker Lead (BML), represents biomarker functions in the clinical development team thereby providing clinical development and biomarker strategies to achieve internal decision milestones such as PoC.
• Applies integrative leadership skills to coordinate a cross‑functional team of experts to ensure timely development of biomarker strategies, contributions to respective documentation (e.g., Clinical Development Plan (CDP)) and presentation at relevant meetings/committees.
• As appropriate, supports trial patient stratification/inclusion and Companion Diagnostics (CDx) development activities.
• Adapts biomarker strategy based on novel study results.
• As a Core Team member, represent Experimental Medicine (Exp Med) and drive Exp Med aspects throughout clinical development and ensure timely delivery.
• Provides relevant sections to the investigator's brochure (IB).
• Be accountable for all clinical operational aspects including budget oversight from start of clinical development up to launch (“end‑to‑end integration”).
• Reports to relevant governance bodies with respect to strategic & study content related aspects as well as operational clinical & budget related aspects.
• As a member of the disease area biomarker team, provides clinical biomarker strategy on a disease area level, generates an aligned and actionable disease area biomarker…