Global Project Manager- Personalized Healthcare

Global Project Manager- Companion Diagnostics

Large, international medical diagnostics company is expanding their team with a new Global Project Manager. Work with internal and external stakeholders to bring life saving cancer diagnostics to market to enable patients to achieve better outcomes!

This position will be hybrid working approximately 2 days per week at our north Tucson campus. Daytime hours, Monday Friday.

A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

As part of the Project Management Chapter (PMC), the Global Project Manager (GPM) plays a key role in optimized product delivery, accountable for all project management aspects of various projects from simple to complex in nature. Drives the project/product from the original concept through completion by developing and directing detailed work plans, schedules, project estimates, spending, resource plans, and status reports. As a trusted advisor, the GPM translates and drives projects into products and enables the organization to use energy and time effectively and efficiently while quickly responding to changing business needs across the portfolio.

The Opportunity:

-You will drive the delivery of innovative Companion Diagnostics projects, working with both internal project stakeholders as well as external Pharma partners.

-You will own project/program/product structures for product development and product care activities, including communication management, timelines, resource and budget plans, progress, and cost control.

-You will create, coordinate, and maintain integrated project plans, including dependencies, resources, and budgets, allowing your teams to work efficiently and effectively. You will be accountable for quality implementation in complex projects in the following areas: project risk management, critical path analysis, scenario creation and analysis, budget analysis, and robust planning.

-You will identify project risks and describe potential implications for budget, timeline, and scope. You will proactively identify gaps, potential bottlenecks or delays, challenge assumptions, and propose innovative options to close gaps and get complex projects back on track while communicating issues proactively to stakeholders.

-You will consistently execute project management processes, including guiding and managing preparation for milestone reviews, capacity reviews (cQCR, SCR & fQCR), etc., as applicable, and may lead improvement initiatives. You will implement 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 lead meetings and foster knowledge sharing between project/product teams to enhance project effectiveness and optimized delivery.

-You will establish, measure and report 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 holistic planning, project risk management, scenario creation as well as critical path analysis, with the aim to ensure optimized value delivery. You will be the single point of contact and control for project and program data collected from the functions.

-You will manage project/product team information to support your teams themselves, the Life Cycle Teams (LCTs), and/or other governing body decision-making. Frequently, you will provide high-level, pre-defined and recent planning data for scenario analysis and decision-making on a portfolio level. You will act as Agile Program Manager as defined by Scaled Agile Framework (SAFe) where applicable.

Who You Are:

-You have demonstrated experience using Planisware, MS-Office, G-Suite and "know-how" of project management tools such as Trello, LucidChart, Smartsheet, Jira, Azure DevOps, etc.

-You have demonstrated profound problem-solving skills and critical thinking with the ability to synthesize information to identify relevant insights that will advise improvement opportunities

-You have a reputation for proactively and successfully driving the delivery of high-complex product development projects, from conceptualization to commercialization.

-You have demonstrated interpersonal and influencing skills with an established ability to drive decisions; you have demonstrated ability to identify, facilitate and communicate issues proactively to a wide range of stakeholders

-You have strong communication skills (both verbal and written) and presentation skills to enable effective cross-functional collaboration

-You have a profound understanding and knowledge of relevant Design Control and/or Phased Development processes

-You have a profound understanding and knowledge of healthcare quality, risk, and/or regulatory compliance

-You demonstrate good strategic and tactical thinking, and profound analytical thinking.

-You have the ability to escalate and drive management decisions in relation to project execution and resource needs.

-You have a value delivery mindset.

Bachelor's degree (from an accredited institution) in science, engineering or business related fields

4+ years project management experience in the diagnostic, medical device, health science, pharmaceutical or biotech industry leading complex new, product development and product care projects. Project management experience in other regulated industries will also be considered.

Knowledge in clinical biomarker or In Vitro Diagnostic development, companion diagnostic development, analytical and clinical validations and regulatory submissions or instrument development and program management

1+ year of experience in a regulated industry (e.g. FDA 21 CFR part 820, ISO 13485, ISO 9001)

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.