Associate Director, Translational Medicine – Clinical Biomarkers

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the formulation and implementation of clinical biomarker strategies for CML and various oncology initiatives.

• Perform landscape evaluations and assess biomarker testing options from CROs and clinical laboratories.

• Direct the development, transfer, optimization, qualification, and validation of biomarker assays for hematologic malignancies and liquid-tumor applications.

• Ensure that assay validation and implementation align with the intended use and clinical context.

• Establish and oversee partnerships with external laboratories, including defining scope, timelines, deliverables, budgets, risks, change orders, and resolving issues.

• Assess biomarker data for accuracy, completeness, consistency, and biological plausibility.

• Identify issues related to assay performance and sample quality.

• Collaborate with Clinical Development and Clinical Operations on clinical protocols, laboratory manuals, informed-consent documents, sample-collection schedules, biomarker analysis plans, and study reports.

• Work with Regulatory Affairs on biomarker and companion diagnostic strategies, regulatory submissions, briefing packages, addressing health authority queries, and interactions with the FDA, EMA, and other regulatory bodies.

• Offer expertise on regulatory expectations concerning exploratory biomarkers, clinical trial assays, investigational device exemptions, companion diagnostics, laboratory-developed tests, and in vitro diagnostic development.

• Partner with Quality Assurance to qualify biomarker CROs and laboratories, and assist with vendor audits.

• Ensure the resolution of audit findings and the implementation of corrective and preventive measures.

• Review vendor invoices to ensure alignment with contracts, statements of work, completed activities, and deliverables.

⛳️ Requirements

• MD, PhD, or Pharm D in molecular biology, cancer biology, genetics, pathology, laboratory medicine, pharmacology, or a related field with pertinent industry experience.

• An M.S. or B.S. degree with significant directly relevant experience may also be considered.

• 8 or more years of relevant experience for candidates with an advanced degree.

• 15+ years of relevant experience for M.S. or B.S. candidates.

• Experience in pharmaceutical, biotechnology, diagnostic, clinical laboratory, or CRO sectors.

• Extensive experience in developing and implementing biomarker assays in clinical studies, ideally in oncology or hematology.

• Direct experience with molecular testing for hematologic malignancies.

• Strong preference for experience with CML, BCR::ABL1 mutation testing, and molecular-response monitoring.

• Proven experience with NGS, Sanger sequencing, qRT-PCR, and/or digital PCR technologies.

• Experience in selecting, contracting, and managing CROs, central laboratories, diagnostic partners, or other external vendors.

• Familiarity with clinical protocols, biomarker analysis plans, laboratory manuals, clinical sample workflows, and biomarker datasets.

• Experience supporting regulatory submissions or engaging with the FDA, EMA, or other health authorities.

• Strong preference for familiarity with companion diagnostic and in vitro diagnostic development.

• Understanding of clinical biomarker strategy and fit-for-purpose assay-development frameworks.

• Knowledge of analytical-validation principles, including accuracy, precision, analytical sensitivity, specificity, linearity, reportable range, reproducibility, robustness, sample stability, and interference.

• Proficient understanding of regulatory and quality requirements, including FDA and EMA guidance, ICH guidelines, Good Clinical Practices, Good Laboratory Practice principles, CLIA, CAP, ISO 15189, and requirements for investigational and companion diagnostic assays.

• Capability to develop biomarker strategy and convert scientific objectives into actionable clinical plans.

• Ability to critically evaluate emerging technologies, laboratory capabilities, and assay-development proposals.

• Capacity to lead cross-functional initiatives and influence stakeholders without direct authority.

• Skills in vendor management, negotiation, problem-solving, and decision-making.

• Ability to juggle multiple programs, laboratories, and priorities in a dynamic development environment.

• Exceptional written and verbal communication skills.

• Strong focus on detail, data integrity, documentation quality, and regulatory compliance.

• Ability to identify risks early, propose mitigation strategies, and drive issues to resolution.

• Preferred experience with global registration studies and regulatory submissions.

• Knowledge of measurable residual disease, liquid biopsy, circulating tumor DNA, resistance mutations, or other molecular biomarkers in hematologic malignancies is preferred.

• Established relationships with central laboratories, diagnostic companies, or biomarker CROs are preferred.

• Experience supervising employees, consultants, or matrixed project teams is preferred.

• Successful completion of a background check is required.

🏝️ Benefits

• Comprehensive benefits package included.

• Potential for bonuses.

• Possible equity offerings.

• Equal opportunity employer.