Program Leader - Assay Development

Program Leader - Assay Development


Program Leader - Assay Development

Detalles de la oferta

Position Title:Program Leader, Assay Development
Position Summary: 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 biostatistician leads.
Essential Functions:
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 the 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:
A Ph.D. 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 the FDA and other regulatory bodies
Planning and executing 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, Mental, and Environmental Requirements:
Weekend and evening work required in order to meet deadlines. Work is indoors in a seasonally heated and airconditioned environment. The position is sedentary and requires typing and the ability to move objects weighing up to 25 lbs. Occasional travel is required.

Fuente: Jobsxl


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