AOA Dx is developing the next frontier in early-stage cancer detection through its pioneering work in glycolipids and proprietary lipidomic, immunoassay and proteomic biomarker technology. Our revolutionary tumor marker platform, GlycoLocate™, is paving the way for life-saving early cancer detection. In a first of its kind, AOA Dx is developing AKRIVIS GD™, an early-stage liquid biopsy test for ovarian cancer.

About the Role

We are seeking a talented and experienced Director of R&D, LC-MS with a degree in chemistry, biochemistry, or a related field with specific experience in Liquid Chromatography-Mass Spectrometry (LC-MS) method development for regulatory approved clinical testing. In this position, you will be responsible for leading a team tasked with running, troubleshooting, designing and performing high throughput experiments on LC-MS/MS. This role requires experience leading teams, managing individuals and a deep understanding of method development of clinical mass spectrometry assays.

Responsibilities

Strategic Leadership

Define and execute the R&D roadmap for LC-MS clinical assays aligned with company objectives.
Provide technical and scientific leadership for assay design, method development, optimization, and validation.
Anticipate scientific trends and emerging technologies to maintain competitive advantage.

Assay Development

Oversee the development of multi-omic IVD platform using LC-MS assays for protein, metabolite and lipid biomarkers in complex biological matrices.
Lead R&D through all stages of development from concept to launch while ensuring that product meets FDA requirements for launch as respective IVD and/or as CLIA LDT.
Drive manufacturability of product during development to ensure robust design controls, QC procedures and meet COGS targets.
Oversee data deliverables by working with data scientists to drive and interpret assay performance characterization including sensitivity, specificity, linearity, reproducibility, and robustness using various statistical data modeling and machine learning approaches.
Ensure compliance with CLIA, CAP, FDA, ISO 13485, and other regulatory/quality frameworks.

Team & Project Management

Build, mentor, and lead a high-performing team of scientists and associates.
Manage multiple projects simultaneously with clear timelines, budgets, and deliverables.
Collaborate cross-functionally with Clinical, Regulatory, Quality, Operations, and Commercial teams.

External Engagement

Partner with KOLs, academic collaborators, and technology vendors to accelerate innovation.
Represent the company at scientific conferences, consortiums, and industry events.
Stay current with emerging trends and advancements in mass spectrometry technology.

Qualifications

PhD in Analytical chemistry, biochemistry, biology, or chemistry or related field.
Candidates with M.S. or B.S. degrees with compensating expertise and experience will be considered.
Minimum of 4+ years of managing direct reports.
Minimum 2+ years developing discovery and targeted clinical LC-MS assays.
Excellent leadership and mentoring skills.
Proven track record of delivering high-impact projects.
Proficient in managing cross-functional teams and leading complex projects.
Excellent problem-solving, leadership, and communication skills.
Experience working with executive leadership and external partners.
Required years' experience in biotech or pharma industry is based on degree as follows:
9+ years is preferred for candidates with PhD.
10+ years is required for candidates with M.S.
12+ years is required for candidates with B.S.
Preferred experience working with FDA to develop and launch regulatory approved clinical LC-MS IVD and/or CLIA based LDT.
Preferred experience with manufacturability including supplier quality, COGS, QC method development and design & technology transfers.

Pay range and compensation package

The salary range for this position is $165,000 to $200,000 per year, which factors in various geographic regions. The actual compensation and seniority level for this position will be determined based on relevant experience and qualifications. AOA Dx offers competitive benefits, including unlimited PTO, group health, dental, and vision insurance, 100% employee sponsored life and disability benefits, monthly cell phone reimbursement, and a 401k plan with employer match.

Location: Denver, CO: In-Person

To Apply: For consideration, please apply via LinkedIn or email us with your resume referencing “Director, R&D LC-MS” in the subject line to careers@aoadx.com.

Equal Opportunity Statement

AOA Dx is an equal opportunity employer and welcomes candidates from all backgrounds to apply. We foster an environment where all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation or expression, age, disability or veteran status or any other characteristics protected by law.

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