Senior Director, Clinical Product Development
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Job Description
Manage clinical product development teams at Adaptive Biotechnologies, driving innovation in diagnostic assays and products. Collaborate across departments to achieve commercial product goals.
Responsibilities:
- Responsible for managing a team that is responsible for clinical product development activities, which could include technical feasibility, methods development, assay development, design risk management, bioinformatics and software algorithm development, verification and validation (V&V) studies, new indications, support IST data generation, and serve as the technical representative in customer facing meetings for MRD business.
- Collaborate with other departments, including Research, Technical Operations, Medical Affairs, Software, PMO, Integrated Supply Chain, Quality & Regulatory, Clinical Lab Director, Legal, Finance, Equipment Engineering, and Commercial to achieve the goal of developing assay prototypes to commercial products.
- Communicates plans, proposes short- and long-term strategies, timelines, and results to executive level and with stakeholders across the organization.
- Guides decision-making and scientific mentorship
- Manages team members performance and career development
- Seen as Adaptive’s SME regarding product development work, which includes strong understanding and contributes to results analysis of NGS immunosequencing data and complex statistical analyses.
- Write and edit study reports, with analysis support from technical experts from the larger team.
- All other duties as assigned.
Requirements:
- PhD (or advanced degree) in molecular genetics, immunology, bioengineering or related field
- 10+ years of experience in a diagnostic, medical device or life sciences company
- Experience managing subordinate managers
- Minimum of 5 years of Product Development Process (PDP) experience with regulated IVD product development under design control, including verification and validation activities
- prior experience with NGS diagnostic product commercialization strongly preferred
- Demonstrated experience in ISO, CLIA, CAP, CLEP, FDA, IVDR, GxP or equivalent regulatory compliance requirements required
- Familiarity with the application of basic statistical analyses required
- Excellent technical scientific writing, communication, and organizational skills, with significant attention to detail
- Experience in hematology, oncology, immunology with NGS technology is preferred
- Prior experience with JMP, R or other statistical analysis software preferred.
Benefits:
- equity grant
- bonus eligible
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