Senior Oncology Biomarker Lead, Clinical Development

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Ridgefield (CT)

On-site

USD 170,000 - 269,000

Full time

2 days ago

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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

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.

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