Associate Director, Translational Medicine – Clinical Biomarkers

Job not on LinkedIn

🔥 8 minutes ago

🇺🇸 United States – Remote

💵 $205k - $230k / year

⏰ Full Time

🟠 Senior

🌎 Translator / Interpreter

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Enliven Therapeutics

WebsiteLinkedInAll Job Openings

11 - 50 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Enliven Therapeutics is a company dedicated to developing innovative solutions for cancer treatment. They focus on creating small molecule kinase inhibitors designed to improve efficacy, safety, and patient convenience. With programs targeting BCR-ABL, HER2, and additional pathways, Enliven Therapeutics aims to enhance the precision and selectivity of cancer therapeutics, combat resistance, and address brain metastases. The company prides itself on a team of experienced drug developers and aims to help cancer patients live longer and better lives.

📋 Description

• Lead development and execution of clinical biomarker strategies for CML and other oncology programs • Conduct landscape assessments and evaluate biomarker testing solutions from CROs and clinical laboratories • Lead development, transfer, optimization, qualification, and validation of biomarker assays for hematologic malignancies and liquid-tumor applications • Ensure assay validation and implementation are appropriate for intended use and clinical context • Establish and manage external laboratory partnerships, including scope, timelines, deliverables, budgets, risks, change orders, and issue resolution • Evaluate biomarker data for accuracy, completeness, consistency, and biological plausibility • Identify assay-performance and sample-quality issues • Partner with Clinical Development and Clinical Operations on clinical protocols, laboratory manuals, informed-consent language, sample-collection schedules, biomarker analysis plans, and study reports • Collaborate with Regulatory Affairs on biomarker and companion diagnostic strategies, regulatory submissions, briefing packages, health-authority questions, and interactions with FDA, EMA, and other authorities • Provide expertise on regulatory expectations for exploratory biomarkers, clinical trial assays, investigational device exemptions, companion diagnostics, laboratory-developed tests, and in vitro diagnostic development • Work with Quality Assurance to qualify biomarker CROs and laboratories and support vendor audits • Ensure resolution of audit findings and implementation of corrective and preventive actions • Review vendor invoices against 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 discipline with relevant industry experience • M.S. or B.S. degree with substantial 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 • Relevant pharmaceutical, biotechnology, diagnostic, clinical laboratory, or CRO experience • Significant experience developing and implementing biomarker assays in clinical studies, preferably in oncology or hematology • Direct experience with molecular testing for hematologic malignancies • Experience with CML, BCR::ABL1 mutation testing, and molecular-response monitoring strongly preferred • Demonstrated experience with NGS, Sanger sequencing, qRT-PCR, and/or digital PCR technologies • Experience selecting, contracting, and managing CROs, central laboratories, diagnostic partners, or other external vendors • Experience with clinical protocols, biomarker analysis plans, laboratory manuals, clinical sample workflows, and biomarker datasets • Experience supporting regulatory submissions or interactions with the FDA, EMA, or other health authorities • Familiarity with companion diagnostic and in vitro diagnostic development strongly preferred • 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 • Working knowledge of applicable 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 • Ability to develop biomarker strategy and translate scientific objectives into executable clinical plans • Ability to critically assess emerging technologies, laboratory capabilities, and assay-development proposals • Ability to lead cross-functional initiatives and influence stakeholders without direct authority • Vendor-management, negotiation, problem-solving, and decision-making skills • Ability to manage multiple programs, laboratories, and priorities in a fast-paced development environment • Excellent written and verbal communication skills • Strong attention to detail, data integrity, documentation quality, and regulatory compliance • Ability to identify risks early, recommend mitigation strategies, and drive issues to resolution • Experience with global registration studies and regulatory submissions preferred • Knowledge of measurable residual disease, liquid biopsy, circulating tumor DNA, resistance mutations, or other molecular biomarkers in hematologic malignancies preferred • Established relationships with central laboratories, diagnostic companies, or biomarker CROs preferred • Experience supervising employees, consultants, or matrixed project teams preferred • Successful completion of a background screen required

🏖️ Benefits

• Benefits are included • Bonus may be provided • Equity may be provided • Equal opportunity employer