Senior Director, Clinical Product Development

Adaptive Biotechnologies • Seattle, WA

10h • Remote

About The Position

At Adaptive, we’re 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, you’ll have the opportunity to make a difference in people’s lives. With Adaptive, you’ll create a career highlight through collaboration with bright, curious colleagues working at the apex of innovation and application. It’s time for your next chapter. Discover your story with Adaptive. Position Overview The Sr Director, Clinical Product Development will manage a scientific, bioinformatics, and software algorithm development teams which is responsible for the development of Adaptive Biotechnologies clinical assays and products. This role also supports Real World Data generation and software algorithm development to enhance capabilities for the clinical lab and manufacturing. 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 every day.

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
• 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.

Nice To Haves

• 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.
• Experience in hematology, oncology, immunology with NGS technology is preferred.
• Prior experience with JMP, R or other statistical analysis software preferred.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree