Seeking a Project Manager who has worked in Biotech, Pharma or other regulated environment (FDA, ISO, CLIA and CAP regulations)
We are dedicated to transforming the way in which patients with cancer are diagnosed and treated. At Foundation Medicine, Inc. (FMI) you will work with everyone fighting the diseasepatients and their families, payers, physicians, drug developersto raise awareness about the ongoing evolution in cancer care and to ensure we are delivering the analytic tools and molecular information required to bring the promise of personalized cancer care into routine clinical practice. As a member of our Portfolio and Program Management Office team you will be responsible for leading projects to provide best-in-class products and services that empower the work and research of physicians, researchers, and all those engaged in the fight against cancer around the globe.
Summary of Position:
The Sr. Project Manager is responsible for the planning and execution of new biopharma clinical product development and lab expansion projects, as well as other business-critical initiatives. Responsibilities include development and execution of project plans to deliver the defined solution business case, identification and resolution of project resource requirements and issues, and developing and managing the project deliverables. These responsibilities span from product concept to global commercialization to business operations.
Leads project through the entire product development/project management lifecycle.
Develops and implements project plan, including scope, schedule, risk, resource and communications plans.
Builds team ownership and commitment to project plans.
Provides structured thinking to project team on overall approach and delegates as appropriate.
Focuses on Voice of Customer, Voice of Business, personal accountability, and an unyielding commitment to results.
Guides the team in appropriate decision-making through strong judgment and the ability to analyze options and implications.
Communications and Reviews:
Responsible for team and cross-functional communications (written and oral).
Acts as liaison between the team and FMI governance (Portfolio Governance Committee, Executive Team), as required.
Coordinates and guides project phase reviews; defines and tracks key project metrics.
Elevates critical business decisions to the appropriate committees, management teams and/or functional managers.
Provides input to functional leaders on team and team member performance.
Develops and maintains strong relationships with functional leaders to drive success of projects and teams.
Influences cross-functional collaboration.
Product Development Lifecycle (PDLC) and Project Management Life Cycle (PMLC) system knowledge through delivery of high quality and high impact deliverables.
Knowledge of quality system use for the creation and continued compliance of products.
Actively reviews policy and practice improvements to drive functional excellence.
Influences cross-functional systems effectiveness.
Team Management Requirements:
Will lead a team of cross-functional representatives in the achievement of organizational goals.
Influence in a complex, matrixed environment.
Foster a team environment that enables all participants to contribute to their full potential in pursuit of project objectives.
Monitor and ensure compliance with company policies and procedures in support of project launch and operational activities (e.g., federal/country and regulatory requirements).
Excellent communication skills; comfortable in front of all levels of the organization, as well as external customers.
Proficient project management skills and principles, including scope, schedule, resource and risk management.
Strong leadership, negotiation and conflict management skills.
Proven experience with Waterfall methodology.
Familiarity with Agile methodology.
Experience using project management tools.
Capable of working independently under ambiguous and/or changing conditions.
Demonstrated ability to function independently with deadline and resource constraints.
Demonstrated ability to coordinate across disciplines and integrate all aspects of business as they impact development projects, including negotiation of scope, roles and responsibilities, specifications, timelines, and resources up, across, and down in the organization.
Position is based in Cambridge, MA.
Required Education, Knowledge and Expertise:
5-7+ years of experience in a project management role.
Demonstrated expertise leading international and/or distributed mid-to-large scale product development projects utilizing project management and product design & development frameworks.
Advanced degree (MS, PhD, MBA) and/or advanced project management certification (PMP) is desirable.
Knowledge of and work experience with FDA regulated products.
Previous experience managing lab development/expansion programs.
Experience working with intercultural teams.
Working knowledge of FDA, ISO, CLIA and CAP regulations.