Global CDx Program Lead

SGS Consulting; Yuma (AZ); On-site; USD 90,000 - 130,000; Full time

Job summary

SGS Consulting seeks a seasoned Project Manager to lead Companion Diagnostics (CDx) development and product care programs. You will own structures, dependencies, budgets, and milestones, and you will drive integrated plans for efficient delivery across cross-functional teams.

You will apply agile methods in a hybrid setup, establish KPIs/OKRs, mentor teams, and act as a trusted advisor for holistic planning and risk management across projects.

Qualifications

• 4 years of experience in project management / engineering / business in diagnostic, medical device, pharmaceutical or biotech industries.
• At least one year in clinical biomarker or In Vitro Diagnostic development or companion diagnostics, validations, regulatory submissions, instrument/systems development or program management.
• At least one year in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).

Responsibilities

• You will own project/program/product structures for CDx development and care activities including communications, timelines, resources and budget plans.
• You will create and maintain integrated plans with dependencies, resources and budgets, enabling teams to work efficiently.
• You will drive integrated project plans, improving quality, efficiency and delivery.
• You will guide project management processes for milestone / capacity reviews and drive improvement initiatives.
• You will apply agile methods as appropriate, coaching teams in agile practices in hybrid roles.
• You will establish and report KPIs/OKRs/OBPs to measure and improve outcomes.
• You will act as trusted advisor and single point of contact for project data and planning.
• You will lead project team meetings and promote knowledge sharing across teams.
• You will identify risks and gaps, and propose options to keep projects on track while communicating issues to stakeholders.
• You will support life cycle teams and decision making with planning data for portfolio level reviews.
• You will serve as an Agile Program Manager per SAFe where applicable.
• Other duties as assigned by leadership.

Skills

Project management

Agile practices

Biotech/diagnostic industry experience

Job description

SGS Consulting seeks a seasoned Project Manager to lead Companion Diagnostics (CDx) development and product care programs. You will own structures, dependencies, budgets, and milestones, and you will drive integrated plans for efficient delivery across cross-functional teams.

You will apply agile methods in a hybrid setup, establish KPIs/OKRs, mentor teams, and act as a trusted advisor for holistic planning and risk management across projects.