VP - Strategic Research & Development Initiative

Biodesix•Louisville, KY

2d•Onsite

About The Position

Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.com. The VP of Strategic Research & Development Initiatives leads the strategic positioning and early commercial valuation of our next generation of precision medicine tests. This executive drives screening and validation of opportunities and promotes insight into existing and new commercial channels that support expanding the strategic reach of the company. The VP Strategic Research & Development Initiatives will assume business portfolio management of all pipeline concepts, aligning Biodesix R&D opportunities in our pipeline, fostering collaboration intended to value these opportunities with internal and external stakeholders, with an eye to expanding our commercialization strategies. The VP of Strategic Research & Development Initiatives partners closely with the Executive team, R&D, Regulatory, Reimbursement, Laboratory Operations and Marketing teams to enhance visibility to the development of the portfolio and maintain contact with the operational Product Development Core teams. They have a strong track record of managing strategic partner relationships at all levels of engagement, and hands-on experiences with deployment of complex diagnostic tests, platforms and systems intended for the global marketplace. With this background the candidate has demonstrated the ability to manage breakthrough multi-omics devices from innovation through clinical market adoption. An understanding of the required regulatory frameworks in the US and global markets that helps ensure that the emerging portfolio aligns with compliance is an advantage.

Requirements

Ability to evaluate emerging technologies, diagnostic opportunities, and market trends to prioritize investments, guide portfolio strategy, and maximize long-term business value.
Demonstrated ability to establish, cultivate, and manage strategic relationships with industry partners, academic institutions, technology providers, and executive stakeholders to achieve organizational objectives.
Ability to lead and influence multidisciplinary teams across research, product development, regulatory, reimbursement, marketing, and executive functions within a highly matrixed environment.
Deep knowledge of molecular diagnostics, biomarker development, precision medicine, and emerging healthcare technologies, with the ability to translate complex science into strategic business opportunities.
Understanding of regulatory, clinical validation, quality, reimbursement, and compliance considerations that impact diagnostic development and commercialization in U.S. and global markets.
Ability to assess complex opportunities, synthesize scientific, clinical, and commercial data, and make informed recommendations that accelerate innovation and organizational growth.
Master’s, Ph.D., M.D., or equivalent in genetics, molecular biology, or oncology relevant discipline.
An MBA is a strong asset.
15+ years in molecular diagnostics, with a clear track record of launching clinical oncology assays (e.g., ctDNA, tissue and blood NGS, immunotherapy biomarkers), devices (examples include PCR, NGS, ELISA, Mass Spec, software systems), and reagent management for complex assays and clinical laboratory workflows.
CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493
CAP: College of American Pathologists (CAP)
NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5
ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016
All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD
Occupational Safety and Health Administration (OSHA)

Responsibilities

Lead the development roadmap for value-based diagnostics, focusing on early detection, therapeutic selection and guidance, and molecular response monitoring (MRD).
Scope novel biomarker tests such as multi-cancer MRD, epigenetics (methylation), and artificial intelligence for potential to be incorporated into a laboratory’s testing strategy.
Establish clinical utility frameworks to differentiate assays in a crowded market, prioritizing tests that solve critical gaps in precision medicine.
Drive valuation studies, establish and monitor productivity metrics associated with cross-functional R&D pipelines connecting bioinformatics, clinical development, and molecular R&D to accelerate the transition from concept to clinical feasibility.
Secure high-value Development Services agreements with life sciences partners, aligning CTA (clinical trial assays), LDT and IVD opportunities with manufacturers of reagents, device platforms and software. Outcomes may include early assessment of pipeline fit beyond initial Services collaborations.
Build strategic alliances with academic medical centers, cooperative trial groups, and national trial design networks to drive data generation.
Support tracking of competitive landscape, identifying targets for Services, strategic consolidation, technology licensing, or co-development.
Integrate with compliance pathways under active regulatory frameworks, proactively preparing the test portfolio for expanded regulatory oversight in US and other markets.
Support scoping of laboratory workflows, robust analytic and clinical validation studies that meet required regulatory and reimbursement standards and satisfy rigorous major academic partner requirements.
Align with regulatory guidance for device and assay validation protocols that leverage regulatory Initiatives, including FDA Oncology Center of Excellence guidelines.
All Other Duties As Assigned.