This position may be hired at the Director or Sr Director level based on the selected candidate's experience and qualifications.
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
Qualifications:
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…