Precision for Medicine
Director, CDx Regulatory Consultant
Remote, United States · Director
Sponsorship not specified$162k-$243kDetected 6 days ago
StatisticsBusiness DevelopmentClinical TrialsPublic HealthFDA RegulatoryMolecular BiologyLeadershipCommunicationPublic SpeakingBiostatisticsRegulatory Affairs
About the role
- Essential functions of the job include but are not limited to:
- Serve as the CDx regulatory subject matter expert for strategic positioning of client programs inclusive of CDx, including relevant FDA precedents, EU IVDR considerations, global submission expectations, and diagnostic commercialization pathways.
- Generate new CDx regulatory consulting opportunities through established relationships with pharmaceutical, biotechnology, diagnostic, laboratory, and precision medicine stakeholders.
Responsibilities
- This role will translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization.
- Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives.
- Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives.
- Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.
- Develop integrated Rx Dx regulatory strategies that align diagnostic development, biomarker strategy, clinical trial enrollment, therapeutic development milestones, and commercialization objectives for pharmaceutical, biotechnology, and diagnostic clients.
- Lead interactions with regulatory authorities and notified bodies, including preparation for FDA meetings, interpretation of agency feedback, development of response strategies, meeting minutes, and follow-up communications on behalf of clients.
- Review and direct the development of analytical validation plans, clinical performance study plans, diagnostic clinical protocols, statistical analysis synopses, technical reports, intended use statements, labeling, and other submission-ready documents for CDx programs.
- Apply IVD quality system, design control, risk management, and post-market regulatory expertise to support CDx readiness from early development through approval, launch, and lifecycle management.
Requirements
- Minimum Required:
- Bachelor's degree in life sciences, molecular biology, genetics, pathology, laboratory medicine, regulatory affairs, or a related scientific discipline
- Minimum 5 years of applicable consulting experience with a primary focus in IVD, companion diagnostic, clinical trial assay, or precision medicine regulatory affairs.
- Minimum of 7 years of experience in an in vitro diagnostic, companion diagnostic, pharmaceutical, or regulatory consulting environment.
- Strong written and verbal communication skills, with demonstrated ability to translate complex CDx regulatory requirements into clear, practical recommendations for clients and cross-functional teams.
- Ability to solve complex CDx regulatory, clinical trial assay, submission, and commercialization challenges with practical, risk-based solutions.
- Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role.
- equivalent relevant experience may be considered.
- Other Required:
- Direct experience working with diagnostic manufacturers/labs and pharmaceutical sponsors to design global regulatory and commercialization strategies for companion diagnostics and clinical trial assays.
- Strong scientific and analytical skills, including the ability to interpret biomarker, assay validation, clinical performance, and diagnostic clinical trial information in support of CDx regulatory strategy.
- Strong leadership, team building, and interpersonal skills, including the ability to guide multidisciplinary teams across diagnostic development, therapeutic development, regulatory, quality, clinical, laboratory, and commercial functions.
- Preferred:
- Master's degree or higher in life sciences, molecular diagnostics, regulatory affairs, public health, laboratory medicine, pathology, or a related discipline.
- RAC certification
Compensation
- $162,000 - $243,000 USD
Benefits
- Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
Equal opportunity
- Equal Opportunity Employer.
- If you are an individual with a disability and require a reasonable accommodation to complete any part of the
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