Senior Clinical Biomarker Lead - Oncology

Jobs2Web; Ridgefield (CT); On-site; USD 170,000 - 269,000; Full time

Job summary

Boehringer Ingelheim seeks a Senior Clinical Biomarker Lead to drive biomarker strategies in early development and support translational medicine for PoC projects. You will ensure study data quality, regulatory alignment, and efficient collaboration with internal teams and external experts.

The role requires MD/PhD with strong clinical biomarker experience, late-stage trial knowledge, and the ability to lead cross-functional initiatives across global teams.

Qualifications

• MD/PhD (Biology, Biochemistry or Pharmacology) with strong practical experience in independent clinical/research activities.
• Minimum five (5) years of experience in a pharmaceutical company's drug development environment or independent clinical research activities in academia preferred.
• Experience in late-stage clinical trials and drug registration.
• Experience with Companion Diagnostics (CDx) in clinical/translational settings.

Responsibilities

• Lead biomarker strategy in early clinical development and contribute to PoC projects.
• Ensure regulatory compliance with ICH GCP for biomarker analyses in trials.
• Coordinate cross-functional teams to develop and execute biomarker plans and documentation.
• Represent Boehringer Biomed biomarker activities to external experts and regulatory bodies.

Skills

Integrative leadership

Biomarker strategy

ICH GCP

Clinical biomarker experience

Education

MD/PhD in Biology/Biochemistry/Pharmacology

Job description

Compensation Data

The base salary range for this position is $170,000.00 to $269,000.00 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 click here.

Description

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.

Duties & Responsibilities

• 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 (ExpMed) and drive ExpMed 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 oversightfrom 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 plan, as well as plans and conducts resulting work-packages within strict timelines and in close collaboration with the relevant therapeutic area in Research and Medicine.
• Strengthens competitive positioning with biomarker-informed insights.
• Develop biospecimen banking strategies for a disease area.
• Initiates and leads exploratory non-interventional studies for biomarker identification and qualification.
• This includes generating a project proposal and plan with strict timelines, budget and deliverables in close collaboration with the respective therapeutic area in Research and Medicine.
• Initiates and leads interactions with external experts and identifies external collaborations on biomarker aspects.
• Acts as a representative of Boehringer to medical experts, expert groups, consortia, and other scientific, medical or regulatory organizations.
• Provides biomarker relevant sections of drug registration dossiers, as applicable
• Supports drug registration by participation in regulatory authority meetings across all territories (e.g., pre-IND, pre-NDA, FDA-, PMDA-, EMA meetings).
• Provides input to responses to regulatory authority queries, as appropriate.

Requirements

• MD/PhD (in Biology, Biochemistry or Pharmacology) with strong practical experience in independent clinical/research activities.
• Minimum five (5) years of experience in a pharmaceutical company's drug development environment or independent clinical research activities in academia preferred.
• Experience in certain therapeutic area and relevant technologies with strong scientific knowledge of the pathophysiology and respective therapies.
• Profound knowledge of an experience in the preclinical and clinical application of biomarkers, their evaluation and analysis and the linkage to pathophysiology and clinical endpoints.
• Ability to communicate effectively and in an integrative manner with internal and external experts and with opinion leaders.

Eligibility Requirements

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.

Desired Skills, Experience and Abilities

• Experience in late-stage clinical trials and drug registration.
• Experience in the use and application of Companion Diagnostics (CDx) in clinical and translational settings to support Precision Medicine strategies.