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Role Description

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.

Critical functions of your role include:

• Helping establish individual team member goals.
• Aligning those individual goals with broader team objectives.
• Ensuring those objectives drive the achievement of company goals.
• Providing thoughtful coaching and consistent feedback to team members.
• Creating an environment of belonging, respect, and open communication.

Key Responsibilities and Essential Functions

• Manage a team responsible for clinical product development activities, including:
  • 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
  • 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
  • Commercial
• Communicate plans, propose short- and long-term strategies, timelines, and results to executive level and stakeholders across the organization.
• Guide decision-making and scientific mentorship.
• Manage team members' performance and career development.
• Act as Adaptive’s Subject Matter Expert (SME) regarding product development work.
• Write and edit study reports, with analysis support from technical experts from the larger team.
• All other duties as assigned.

Qualifications

• 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.

Requirements

• 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.

Working Conditions

• Must have flexibility and willingness to work more than standard hours when necessary, including nights & weekends.
• Travel to Corporate, conferences, and customer meetings as necessary.

Compensation

• Salary Range: $206,400 - $309,600
• Possible “other compensation” elements to include:
  • Equity grant
  • Bonus eligible