Global Project Manager, Companion Diagnostics

About the Role

Key Responsibilities

• Own project/program/product structures for product development and product care activities, including communication management, timelines, resource and budget plans, progress, and cost control.
• Drive integrated project plans, including dependencies, resources, and budgets, to ensure efficient and effective team work.
• Ensure quality implementation in complex projects, including project risk management, critical path analysis, scenario creation and analysis, budget, and robust planning.
• Execute complex project management processes, guide preparation for milestone reviews, capacity reviews, and lead improvement initiatives.
• Implement best practices in project/product teams and promote continuous improvement by sharing knowledge among peers.
• Select and apply appropriate project methodology, including coaching teams in agile practices and working in hybrid Agile roles.
• Lead meetings, foster knowledge sharing, and establish positive team dynamics through team building.
• Lead goal setting, establish, measure, and report KPIs, OKRs, or OBPs to enable teams to improve quality, efficiency, and effectiveness.
• Act as a trusted advisor providing holistic planning, risk management, scenario creation, and critical path analysis to ensure value delivery.
• Identify project risks, describe implications, challenge assumptions, propose solutions, and communicate issues proactively to stakeholders.
• Manage complex project information to support teams and decision-making bodies, providing high-level planning data for scenario analysis.
• Act as an Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable.

Requirements

• Demonstrated experience using Planisware, MS-Office, G-Suite, and project management tools such as Trello, LucidChart, Smartsheet, Jira, ADO.
• Strong problem-solving skills and critical thinking abilities to synthesize information and identify insights.
• Interpersonal and influencing skills with the ability to drive decisions and communicate issues proactively.
• Strong verbal and written communication skills and presentation skills for cross-functional collaboration.
• Profound understanding of Design Control and/or Phased Development processes.
• Knowledge of healthcare quality, risk, and regulatory compliance.
• Good strategic, tactical, and analytical thinking skills.
• Ability to escalate and drive management decisions related to project execution and resource needs.
• Bachelor's degree in science, engineering, or business-related fields.
• 6+ years of project management experience in the diagnostic, medical device, pharmaceutical, or biotech industry leading complex projects.
• 1+ year of experience in clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, validations, regulatory submissions, or instrument development.
• 1+ year of experience in a regulated industry (e.g., FDA 21 CFR part 820, ISO 13485, ISO 9001).

Nice to Have

• Master's degree in science, engineering, or business-related fields.
• Experience with Agile development practices and mindset.
• PMP Certification and SAFe Certification.

Qualifications

• Bachelor's degree from an accredited institution in science, engineering, or business.
• 6+ years project management experience in relevant industries.
• 1+ year experience in clinical biomarker or In Vitro Diagnostic development or related fields.
• 1+ year experience in a regulated industry such as FDA or ISO standards.

Benefits & Perks

• Position offers a salary range of $100,000 - 185,600, with actual pay based on experience and qualifications.
• Discretionary annual bonus based on individual and company performance.
• Benefits detailed at the provided link.