Associate Director, Translational Medicine – Clinical Biomarkers

Enliven Therapeutics

. Lead development and execution of clinical biomarker strategies for CML and other oncology programs .

Posted 10/23/2026full-timeRemote • United StatesSenior💰 $205,000 - $230,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in developing and executing clinical biomarker strategies, particularly in oncology and hematology, with a strong focus on assay development, regulatory compliance, and vendor management. Proven ability to lead cross-functional teams and manage complex projects in a fast-paced environment.

Highest-signal resume keywords

Clinical Biomarker Strategy DevelopmentBiomarker Assay DevelopmentRegulatory Submissions and ComplianceVendor Management and NegotiationMolecular Testing for Hematologic Malignancies

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Biomarker Assay DevelopmentMolecular TestingNGSSanger SequencingQRT-PCRDigital PCRAnalytical Validation PrinciplesClinical ProtocolsBiomarker Analysis PlansRegulatory Compliance

Soft Skills

Problem-SolvingDecision-MakingAttention to DetailCommunication SkillsStakeholder Influence

Tools & Technologies

CRO ManagementLaboratory Information Management SystemsClinical Sample WorkflowsBiomarker DatasetsQuality Assurance Processes

Industry Keywords

OncologyHematologyClinical TrialsCompanion DiagnosticsIn Vitro DiagnosticsFDAEMAGood Clinical PracticesGood Laboratory PracticesISO 15189

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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