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Job type: Permanent

Discipline: Biological Sciences, Medicinal Chemistry, Pharmacology

Location: United States

Senior Director, Clinical Biomarkers - Permanent - Remote

Proclinical Staffing is seeking a Senior Director, Clinical Biomarkers to join an innovative biotech company. This is a permanent role with the opportunity to work remotely.

Skills & Requirements:

Education: PhD degree in Biology, Translational Medicine, or related life sciences areas.
Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development.
Work Experience: Minimum 5 years in translational medicine; 10 years preferred. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.
Skills: Fluent in both verbal and written communication in Chinese and English.

The Senior Director, Clinical Biomarkers will:

Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials.
Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.
Manage study budgets and financial transactions with vendors, ensuring effective resource allocation and cost management.
Develop strategic plans to meet budgetary requirements and successfully integrate companion diagnostic assays into end-of-life trials.
Collaborate closely with internal and external teams to ensure timely project delivery and alignment with objectives.
Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.

If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDSCIC

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