Asssociate Director, Translational Medicine - Clinical Biomarkers

Enliven Therapeutics, Inc.; United States; Remote; USD 205,000 - 230,000; Full time

Benefits offered by this job

Remote work flexibility

Job summary

Enliven Therapeutics, Inc. is seeking an Associate Director of Translational Medicine – Clinical Biomarkers to lead biomarker strategy and testing as part of CML programs.

You will identify and implement biomarker testing solutions, assess CRO capabilities, and build partnerships to enable high-quality biomarker assays in clinical studies. The role requires expertise in molecular biomarker assays for hematologic malignancies, including BCR::ABL1 mutation testing and transcript quantification.

Qualifications

• MD, PhD or PharmD in molecular biology, cancer biology, genetics, pathology, laboratory medicine, pharmacology, or related field.

Responsibilities

• Lead development and execution of clinical biomarker strategies for CML and oncology programs.
• Evaluate biomarker testing solutions from CROs and labs, including FDA/EMA-recognized assays.
• Establish and manage external lab partnerships with scope, timelines, budgets, and risk management.
• Review clinical protocols, lab manuals, and biomarker analysis plans with cross-functional teams.
• Collaborate with Regulatory Affairs on biomarker strategies for submissions and interactions with health authorities.
• Provide expertise on regulatory expectations for exploratory biomarkers and diagnostics.
• Support vendor audits and corrective actions with QA.

Skills

Biomarker strategy

Cross-functional collaboration

Vendor management

Regulatory awareness

Strategic thinking

Education

MD/PhD/PharmD in relevant field

MS/BS with relevant experience

Tools

NGS

Sanger sequencing

qRT-PCR

digital PCR

Job description

Position Title: Associate Director, Clinical Pharmacology

Job Status: Exempt, Full Time

Location: Remote

Department: Clinical Pharmacology

Company Overview

Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer but live better. The Company aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies

Position Summary

The Associate Director, Translational Medicine – Clinical Biomarkers, will lead the identification, evaluation, development, validation, and implementation of biomarker testing solutions supporting clinical development programs, with focus on chronic myeloid leukemia (CML).

This individual will develop clinical biomarker strategies, assess external laboratory and contract research organization (CRO) capabilities, and establish partnerships required to implement high-quality biomarker assays in clinical studies. The role will collaborate closely with Clinical Development, Translational Medicine, Clinical Operations, Regulatory Affairs, Data Management, Quality, and other cross-functional partners to support clinical study objectives and deliver long-term value across the research and development portfolio.

The successful candidate will have expertise in molecular biomarker assays for hematologic malignancies, including BCR::ABL1 mutation testing by next-generation sequencing (NGS) or Sanger sequencing for patient selection and BCR::ABL1 transcript quantification by qRT-PCR or digital PCR for efficacy and study-endpoint assessments.

Key Responsibilities

• Lead the development and execution of clinical biomarker strategies for CML and other oncology programs.
• Conduct landscape assessments and critically evaluate biomarker testing solutions offered by CROs and clinical laboratories, including BCR::ABL1 assays authorized, cleared, approved, or otherwise recognized by the FDA, EMA, or other applicable regulatory authorities.
• Lead the development, transfer, optimization, qualification, and validation of biomarker assays for hematologic malignancies and other liquid-tumor applications.
• Ensure that assay validation and implementation are appropriate for the assay’s intended use and clinical context
• Establish and manage external laboratory partnerships, including project scope, timelines, deliverables, budgets, risks, change orders, and issue-resolution processes.
• Evaluate biomarker data for accuracy, completeness, consistency, and biological plausibility, and identify potential assay-performance or sample-quality issues.
• Partner with Clinical Development and Clinical Operations to review 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 the FDA, EMA, and other regulatory authorities.
• Provide expertise on current regulatory expectations for exploratory biomarkers, clinical trial assays, investigational device exemption requirements, companion diagnostics, laboratory-developed tests, and in vitro diagnostic development
• Work with Quality Assurance to qualify biomarker CROs and laboratories and support periodic or risk-based vendor audits. Ensure timely resolution of audit findings and implementation of corrective and preventive actions.
• Review vendor invoices against contracts, statements of work, completed activities, and agreed deliverables as part of effective vendor and budget management.

Requirements

Education

• An 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.

Experience

• 8 or more years for candidates with Advanced Degree or 15+ years for M.S or B.S. candidates with 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 is 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 working 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 is strongly preferred.

Technical and Regulatory Knowledge

• Strong understanding of clinical biomarker strategy and the fit-for-purpose assay- development framework.
• 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, which may include FDA guidance, EMA guidance, ICH guidelines, Good Clinical Practices Good Laboratory Practice principles, CLIA, CAP, ISO 15189, and relevant requirements for investigational and companion diagnostic assays.

Core Competencies

• Demonstrated ability to develop biomarker strategy and translate scientific objectives into executable clinical plans.
• Strong scientific judgment and ability to critically assess emerging technologies, laboratory capabilities, and assay-development proposals.
• Proven ability to lead cross-functional initiatives and influence stakeholders without direct authority. Strong 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, including the ability to present complex biomarker information to technical and nontechnical audiences. Strong attention to detail, data integrity, documentation quality, and regulatory compliance.
• Ability to identify risks early, recommend practical mitigation strategies, and drive issues to resolution.

Preferred Qualifications

• 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.
• Established relationships with central laboratories, diagnostic companies, or biomarker CROs.
• Experience supervising employees, consultants, or matrixed project teams.

The annual salary range Enliven reasonably and in good faith expects to pay for this position at the time of this posting is $205,000 - $230,000. The actual salary offered will be determined based on factors such as experience, qualifications, skills and expertise, geographic location, and other job-related factors permitted by law. Benefits are included and other incentives such as bonus and equity may be provided. This range is subject to change based on business needs, job scope changes, market conditions, and individual qualifications. Employees and applicants may request the pay range for their position or for a position to which they are applying.

Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.