Project Leader / Sr Project Leader

About the Job

The Project Leader is accountable for delivery of programs and solutions in line with FMI's global product development strategy. This person will provide cross-functional leadership to global project teams through Feasibility & Planning, Execution, and program Launch. This role requires expertise in diagnostics development, is creative and strategic, with strong leadership capabilities across multiple disciplines.

Key Responsibilities

• Responsible for on-spec, on-budget, and on-time delivery of the project(s) or program(s).
• Execute tailored strategy aligned with FMI objectives; set clear direction for the global product development strategy from Feasibility & Planning to Launch.
• Lead team to develop scenarios including alternative development options (cost, time, risk / benefit) for strategic decision making.
• Provide structured thinking to program team on overall development including negotiation of scope, roles and responsibilities, specifications, timelines, and resources.
• Develop strategic options according to the principles of time, cost, risk, and addresses technical, regulatory, business, and operations needs.
• Guides team in making decisions on product design and development leveraging understanding of product specifications, enterprise impacts, timelines, and resources.
• Defines trade-offs in product development with a keen understanding to short- and long-term impacts to product roadmap and enterprise plan.
• Decide on product development pathways in accordance to cross-functional evaluation and risk assessment.
• Ensure optimal blend of team members so that the team is functional from an expertise and interpersonal perspective.
• Ensures all team members and functions are aligned behind the objectives and are working together on delivery of Execution activities, facilitating the removal of roadblocks, and holding team members accountable.
• Set challenging project team goals and ensure that best practices are used to attain these goals.
• Proactively identifies risks and challenges and escalates appropriately.
• Deliver a seamless transition into later stages of development by ensuring early planning and cross-functional involvement / communication in early product development strategy.
• Create a positive team environment that instills trust and ensures clear transparent communications and unifies the team behind the overall goal / vision for the project. Instill a sense of urgency and a strong can-do attitude in team members.
• Coach leaders and key talent within team to accomplish goals, monitor team performance, and develop team members.
• Collaborate closely with the Product Manager to drive product lifecycle.
• Propose best practices and implementation of lessons learned for optimal cross-functional collaborations.
• Lead process improvement, and change management, initiatives across the business to drive the highest quality results.
• Challenge the team and organization to ensure that the best possible performance is achieved.
• Encourage creative or unconventional ideas and ensure that these are exploited by the team, as appropriate.
• Comply with FMI's attendance policies

Basic Qualifications

• Bachelor's Degree in a life sciences field, business, engineering, or a related field
• 12+ years' experience in program execution, including end-to-end product lifecycle with at least 5 years in biotechnology

Preferred Qualifications

• Master's or PhD in a life sciences field, business, engineering or a related field
• Detailed knowledge of and proven track record in clinical diagnostic product development, including: Regulatory and Quality systems frameworks for design controls, validations, manufacturing, and lab processes; Management of complex systems and programs with an ability to make effective decisions based on available data; Understanding of clinical diagnostic markets and customers and translating customer requirements to product design
• Expertise in building relationships based on trust both internal and external to an organization
• Experience leading within a matrix environment and inspiring and guiding teams to deliver results
• Leads with an enterprise mindset and leverages understanding of broad organization
• Builds and grow team members, ensuring they are equipped to execute effectively
• Will "roll up their sleeves" and do work that needs to be done on a small, scrappy team
• Communicates powerfully, to influence at all levels of the company
• Has a bias for action, with a "win as a team" approach
• Operates with a clear vision of what is at stake for patients
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's values: Integrity, Courage, and Passion