Global Project Manager- Personalized Healthcare Solutions

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

Job summary

SGS Consulting seeks a seasoned Project/Program Manager to lead Companion Diagnostics product development and care initiatives. You will own integrated plans, manage dependencies, budgets, and risks, and ensure quality across the portfolio.

In a hybrid Agile environment, you will coach teams, apply SAFe practices where appropriate, and report KPI/OKR metrics to leadership to optimize value delivery and stakeholder alignment.

Qualifications

• 4 years of experience in project management in diagnostics/medical devices/pharma/biotech.
• At least 1 year in clinical biomarker or companion diagnostic development, validations, regulatory submissions, or program management.
• At least 1 year in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).

Responsibilities

• Own project/program/product structures for CDx product development and care activities, including communication, timelines, resources and budgets.
• Create and maintain integrated project plans with dependencies, resources and budgets; ensure quality implementation.
• Lead milestone reviews, capacity reviews, and drive continuous improvement; apply agile methods as appropriate.
• Establish KPIs/OKRs to measure value delivery and advise leadership on portfolio decisions.

Skills

Project management

Agile/SAFe

Life sciences focus

Education

Bachelor's degree in a relevant field

Job description

Job Responsibilities

You will own project/program/product structures for Companion Diagnostics (CDx) product development & product care activities including communication management, timelines, resource and budget plans, progress and cost control, and risk management. You will create, coordinate, and maintain integrated project plans including dependencies, resources and budgets, allowing the teams to work efficiently and effectively. You are accountable for quality implementation in projects in the following areas: Project risk management; Critical path analysis; Scenario creation and analysis; Budget; Robust planning. You will proactively own and drive integrated project plans including dependencies, resources and budgets allowing the teams to work efficiently and effectively. You will execute project management processes including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable & may lead improvement initiatives. You will follow best practices in project/product teams and foster continuous improvement by sharing best practices and knowledge among peers. You will select project methodology and apply agile methods as appropriate, including coaching and guiding teams in project methodology, including agile practices (with Project/Program Leads or PMC management if appropriate). You have expertise in working in a hybrid Agile role, combining Agile methods (usually within the project/product team) with non-Agile techniques (usually needed with partners and some functions). You will establish, measure, and report the Key Performance Indicators (KPIs), standard metrics, Objectives and Key Results (OKRs) or Outcome Based Planning (OBPs) key results for projects enabling teams and functions to measure and improve quality, efficiency and effectiveness. You will act as a trusted advisor with a 360° view on all levels to advise and support the project/product teams as well as the broader organization in the holistic planning; project risk management; scenario creation as well as critical path analysis with the aim to ensure an optimized value delivery. You will serve as a single point of contact & control for project and program data collected from the functions. You will lead project team meetings and foster knowledge sharing between project/product teams and sub-chapters to enhance project effectiveness and optimized delivery. You will identify project risks and describe potential implications for budget, timeline and scope. You will identify gaps, potential bottlenecks or delays, challenge assumptions and propose options to close gaps and get projects back on track while communicating issues proactively to stakeholders. You will manage project/product team information to support the teams themselves, the Life Cycle Teams (LCTs) and/or other governing body decision making. Frequently provides high level/pre-defined and recent planning data for scenario analysis and decision making on a portfolio level. You will serve as an Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable. Other duties as assigned by leadership.

Skills

You have 4 years of experience in project management / engineering/ business in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects. You have at least one year of experience in the following areas: clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management). You have one year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).

Education/Experience

You have 4 years of experience in project management / engineering/ business in the diagnostic, medical device, pharmaceutical or biotech industry leading product development and product care projects. You have at least one year of experience in the following areas: clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations, regulatory submissions, instrument/systems development, or program management). You have one year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001).