Program Leader, Assay Development
We are seeking a highly motivated and talented Program Leader with a successful track record of leading multi-functional teams to drive product development. This role will report to the VP of Assay Development and will have oversight for program teams, including project managers, development scientist leads and biostatician leads.
- Responsible for managing one or more assay development programs, including Companion Diagnostics (CDx) programs
- Will serve as the face of the program, as well as the face of the Company to the pharma partner on the CDx program(s)
- Responsible for meeting requirements of program contracts
- Coordinates timelines for projects; tracks progress of cross-functional core team activities
- Owns budget development and tracking for the program
- Owns staffing plan for program success
- Engages customer and cross-functional partners on program management
- Manages 3rd party contracts and services aligned with program objectives (CRO, CLIA Labs, etc.)
- Identifies risks, potential bottlenecks or delays and proposes options to overcome these
- Functions as the single point of control for program data and reports
- Guides and manages preparation for design reviews and phase exits
- Identifies and implements continuous process improvement initiatives to improve efficiency and productivity of assay development
MINIMUM QUALIFICATIONS: Education:
A PhD in Molecular Biology, Biochemistry, Biotechnology or a related science discipline is preferred. An equivalency of experience and an MS in related disciplines may be substituted as appropriate.
- 8+ years’ product development experience in IVD or medical device industry
- Proven track record of developing FDA-approved diagnostic products under Design Control from conception to commercialization
- Support of regulatory submissions, and interactions with FDA and other regulatory bodies
- Planning and executing of project plans
- Establishment of design inputs and manufacturing requirements
- Ability to manage multi-million-dollar budgets
- Previous team leadership experience
Knowledge, Skills, and Abilities:
- Demonstrated track record of understanding and following industry standards (e.g., CLSI) for verification and validation activities
- Strong problem-solving skills and coordination of project related activities
- Good written and verbal communication skills
- Strong team leadership skills
PHYSICAL REQUIREMENTS / ENVIRONMENT:
- Weekend and evening work required in order to meet deadlines.
- Work is indoors in a seasonally heated and air-conditioned environment.
- The position is sedentary and requires typing and the ability to move objects weighing up to 25 lbs.
- Occasional travel is required.