Associate Director, Clinical Product Development

Position Overview

The Associate Director, Clinical Product Development (CPD) will lead a multi-functional team of scientists responsible for the development and validation of Adaptive’s clinical diagnostic assays from Concept through Launch. This position will lead assay development for new assays and product extensions for the clonoSEQ MRD franchise including expanding the intended use to additional diseases, sample types and analytes in the US (IVD, CLIA/CAP LDT) and expanding internationally (e.g. CE-IVD and other regulatory pathways). This role is responsible for overseeing development of analytical validation plans, and supporting clinical validation plans, for these projects.  

In conjunction with scientific leadership, this position will represent CPD on cross-functional project core teams. In this capacity, the Associate Director will lead project teams through the Product Development Process (PDP) from project inception through launch, working closely with partner organizations (Commercial, Medical, Software, Regulatory, Technical Clinical Operations, Quality, Clinical Lab Directors etc.) and provide updates and recommendations to senior leadership. The Associate Director will be responsible for coaching their team on Design History File (DHF) and Risk Management documentation and will ultimately be accountable for delivering a complete DHF in compliance with applicable regulations, standards, and guidances (FDA 21 CFR Part 820, ISO 13485, ISO 14971, IVDR, CLSI etc.)

Leaders at Adaptive demonstrate behaviors consistent with Adaptive’s Core Values and Leadership Principles. Critical functions of your role include helping establish individual team member goals, aligning those individual goals with broader team objectives, and ensuring those objectives drive the achievement of company goals. Providing thoughtful coaching and consistent feedback to your team members will drive performance excellence and accountability, as well as support your team members’ growth and development. Leaders at Adaptive create an environment of belonging, respect, and open and honest communication everyday.

Key Responsibilities and Essential Functions

• Lead the team responsible for clinical assay development and validation activities including technical feasibility, methods development, assay development and optimization, design risk management, and verification and validation (V&V). Technical development spans: sample requirements (specimen types, analyte, collection tubes, shipping), pre-analytical sample preparation, analytical assay steps (reagents, workflow, equipment) to algorithm/analysis methodology assessment, QC criteria, and end-to-end robustness to real word variability. Develops innovative solutions to resolve complicated technical challenges.
• Provide scientific leadership and decision making for their team including experimental design/planning, analysis, result review, and data summarization/presentation. Collaborates closely with Computational Biology/Biostatistics team to analyze and interpret complex data sets and results.
• Contribute to product pipeline strategy by identifying and exploring potential opportunities to expand clinical use cases for existing assays and/or evaluate new technology platforms.
• Partners with Technical Clinical Operations team during design specification handoff to ensure they can successfully execute design transfer to Clinical Laboratory Operations and Manufacturing.
• Collaborate with cross-functional project core teams to identify product design requirements (clinical user, lab technician user, and operational/business) and ensure they are fulfilled. Defines the scope of development activities: experimental plans, defining key development deliverables, milestones, dependencies, and overseeing their execution.
• Responsible for design control activities, authoring and reviewing design control deliverables (e.g. requirements, specifications) and risk management documents (e.g. FMEA) to support IVD products.
• Provides project status reports and timeline updates in collaboration with project management for communication to senior leadership.  
• Implements development best practices, mentor managers (and indirectly, bench scientists), and manages team performance and career development.

Position Requirements (Education, Experience, Other)

Required

• Advanced degree (PhD) in molecular genetics, immunology, bioengineering, or related field and 8+ years of experience (MS with 10+ years, BS with 12+) in assay research and development
• 4+ years of experience in a diagnostic, medical device or life sciences company
• 4+ years of supervisory experience

Preferred

• Demonstrated expertise in leading successful assay development. Deep understanding of molecular biology, genomics, multiplex PCR, NGS technology, sequencing data analysis and statistical analysis. Experience designing and executing projects that answer critical questions.
• Experience developing IVD or CLIA assays under design control including design transfer, verification, and validation activities necessary for diagnostic product commercialization meeting FDA CFR 820, ISO 13485, ISO 14971, and/or CLIA/CAP, CLEP. Familiarity with CLSI guidelines.
• Experience interacting with regulatory agencies (e.g., FDA, Notified Bodies) for assay development and submission
• Demonstrated ability to collaborate with team members across the organization and work on cross functional teams. Ability to communicate, present, and discuss scientific findings with staff members across the organization at all levels from Research Assistants to senior leadership.
• Experience in hematology, oncology, immunology with NGS technology
• Prior experience with statistical analysis: sampling plans, power analysis, statistical analysis software (e.g., JMP, R)
• Understands project management methodologies and capable of providing leadership for projects
• Excellent technical scientific writing, communication, and organizational skills, with significant attention to detail.

Working Conditions

Work is performed in an office environment but may occasionally work in a laboratory handling human biological specimens. Must also have flexibility and willingness to work more than standard hours when necessary, including nights & weekends, etc.  Travel to Corporate, conferences, and customer meetings as necessary.

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Compensation

Salary Range: $144,600 - $217,000

Other compensation elements include:

• equity grant
• bonus eligible