Director, Early Precision Medicine Regulatory Affairs
Scorpion Therapeutics, Rancho Santa Fe, California, United States
Role Summary
The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and diagnostics, focusing on early-stage development through proof of concept and supporting registrations. This role establishes scalable frameworks for investigational assay development, ensuring timely, compliant submissions that support patient stratification in Phase I/II studies. As a key member of the Translational Medicine CLIA Laboratory Steering Committee, the director drives coordinated early-stage drug-diagnostic strategies and health authority engagement to accelerate access to precision therapies. The position demands deep scientific and regulatory expertise (US, EU, Canada, PMD, TGA or Global Devices/IVD preferred), cross-functional leadership, and a commitment to innovation in early precision medicine.
Responsibilities
Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic tests-enhancing the impact and value of our medicines across therapeutic areas.
Design and operationalize a scalable regulatory framework within BMS that supports both internal investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development-ensuring strategic alignment with business needs and enabling timely, compliant submissions
Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies-enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic submissions, proactive health authority engagement, and robust risk mitigation planning.
Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review-ensuring diverse expertise is integrated to drive precision medicine innovation.
Oversee global precision medicine submissions and health authority interactions-including PSAs, SRD, Pre-subs, IDEs, including international related submissions for investigational use only assay in clinical studies-in partnership with the Precision Medicine Lead
Provide regulatory support on product partnership, vendor management and business development opportunities
Serve as a strategic regulatory thought leader by actively shaping policy through trade association engagement and maintaining deep awareness of scientific, competitive, and diagnostic industry trends-acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS.
Engages with stakeholders on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions
Qualifications
Degree Requirements: Solid scientific background, PhD., M.D., PharmD, MS
Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years
Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development-including US, EU, Canada, Australia, Japan, China submissions, etc.-with proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval
Biomarker & CDx Strategy: Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization
Regulatory Leadership & Strategic Planning
Proven ability to lead teams through complex health authority interactions and issue resolution, with deep expertise in developing and executing global regulatory strategies across drug and device development
Regulatory Standards Mastery: GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH guidelines
Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear insights for senior leadership and cross-functional teams; strong partnerships in matrixed environments
Influence & Decision Making: Demonstrates accountability and strategic influence; capable of leading teams to timely, high-quality regulatory decisions balancing innovation, compliance, and enterprise impact
Inclusive Leadership & Continuous Improvement: Values diverse perspectives and continuous improvement
Travel: Up to 20%
Additional Requirements
Travel Up to 20%
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Responsibilities
Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic tests-enhancing the impact and value of our medicines across therapeutic areas.
Design and operationalize a scalable regulatory framework within BMS that supports both internal investigational assay development and clinical specimen testing, while overseeing external investigational use only assay development-ensuring strategic alignment with business needs and enabling timely, compliant submissions
Serve as the regulatory lead on the Translational Medicine CLIA Laboratory Steering Committee, providing strategic guidance and hands-on execution in the design, development, and testing of investigational use assays for patient selection and stratification in BMS Phase I/II studies-enabling business agility and advancing our commitment to precision medicine by ensuring the right drug reaches the right patient at the right time.
Champion innovative regulatory strategies to resolve complex challenges and accelerate patient access, while ensuring early integration of precision medicine approaches-including coordination of key regulatory and clinical documents to support drug and diagnostic submissions, proactive health authority engagement, and robust risk mitigation planning.
Cultivate inclusive, high-impact collaboration with Precision Medicine, Research teams, Global and Regional Regulatory Leads, Global Regulatory Operations, and Quality by delivering timely, strategic guidance in health authority engagements and policy review-ensuring diverse expertise is integrated to drive precision medicine innovation.
Oversee global precision medicine submissions and health authority interactions-including PSAs, SRD, Pre-subs, IDEs, including international related submissions for investigational use only assay in clinical studies-in partnership with the Precision Medicine Lead
Provide regulatory support on product partnership, vendor management and business development opportunities
Serve as a strategic regulatory thought leader by actively shaping policy through trade association engagement and maintaining deep awareness of scientific, competitive, and diagnostic industry trends-acting as a trusted resource for institutional knowledge and informing precision medicine decision-making across BMS.
Engages with stakeholders on a regular basis to better understand organization needs and risk areas and identify pragmatic impactful solutions
Qualifications
Degree Requirements: Solid scientific background, PhD., M.D., PharmD, MS
Significant experience in regulatory affairs and diagnostic-related development e.g., >8-10 years
Scientific & Diagnostic Expertise: Deep expertise in global diagnostic development-including US, EU, Canada, Australia, Japan, China submissions, etc.-with proficiency in IHC, NGS, PCR, and/or mass spectrometry, spanning assay design through regulatory approval
Biomarker & CDx Strategy: Extensive experience in designing regulatory strategies for companion diagnostics and biomarkers, with deep expertise in assay and IVD development-including analytical validation, clinical development, manufacturing, and global regulatory submissions through commercialization
Regulatory Leadership & Strategic Planning
Proven ability to lead teams through complex health authority interactions and issue resolution, with deep expertise in developing and executing global regulatory strategies across drug and device development
Regulatory Standards Mastery: GCP, GLP, CLIA, HIPAA, 21 CFR Parts 11, 312, 812, 820, ISO 13485, ISO 14971, EU IVDR, CMDR, TGA, PMDA, NMPA, ICH guidelines
Communication & Collaboration: Skilled in translating complex scientific and regulatory concepts into clear insights for senior leadership and cross-functional teams; strong partnerships in matrixed environments
Influence & Decision Making: Demonstrates accountability and strategic influence; capable of leading teams to timely, high-quality regulatory decisions balancing innovation, compliance, and enterprise impact
Inclusive Leadership & Continuous Improvement: Values diverse perspectives and continuous improvement
Travel: Up to 20%
Additional Requirements
Travel Up to 20%
#J-18808-Ljbffr