Associate Director, Clinical Product Development

At Adaptive were Powering the Age of Immune Medicine. Our goal is to harness the power of the adaptive immune system to transform the way diseases are diagnosed and treated.

As an Adapter youll have the opportunity to make a difference in peoples lives. With Adaptive youll create a career highlight through collaboration with bright curious colleagues working at the apex of innovation and application.

Its time for your next chapter. Discover your story with Adaptive.

Position Overview

The Associate Director Clinical Product Development (CPD) will lead a multi-functional team of scientists responsible for the development and validation of Adaptives 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 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 Adaptives 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.

Compensation

Salary Range: $144600 - $217000

Other compensation elements include:

• equity grant
• bonus eligible

ALERT: Malicious groups posing as Adaptive employees have recently used fraudulent email aliases to extend employment offers provide fake documents and request sensitive personal and financial information. Legitimate Adaptive employment opportunities are initiated through our careers page and extended after multiple interviews with verified employees. Adaptive does not ask new hires to purchase anything out-of-pocket including home office supplies and equipment.

Interested in this position but dont meet all the requirements Adaptive is committed to building diverse equitable and inclusive teams across our organization. Please consider applying even if your experience doesnt match all the qualifications; you may be the exact candidate were searching for!

Adaptive is not currently sponsoring candidates requiring work authorization support for this position.

Adaptives posted compensation information includes a base salary (or hourly rate) range and summary of other available total compensation. The base salary range represents a minimum-to-maximum salary (or hourly rate) available to candidates upon extension of offer. Base salary is thoughtfully considered upon offer and is determined through multiple evaluation checks throughout the interview process including: a candidates ability to meet minimum qualifications (skills/experience/education) a candidates ability to thoughtfully address preferred qualifications current market conditions and internal pay equity. Listed base salary is exclusive of bonus commission equity differential pay benefits and other incentives.

Adaptives benefits at-a-glance.

Adaptive Biotechnologies is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against based on disability. Please refer theKnow Your Rights: Workplace Discrimination is Illegal Posterfor more information. If youd like to view a copy of the companys affirmative action plan or policy statement please email.

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