Dir, Site Enablement & Product Operations

Foundation Medicine•Boston, MA

50d•$160,000 - $200,000•Hybrid

About The Position

The Director, Site Enablement & Product Operations leads a team of experts that provide leadership and support for all Lab Operations development related aspects of the Product organization and is accountable for policies and procedures relating to Design Transfers and Site Enablement for all of FMI's assays. This position is accountable for the success of FMI's portfolio from concept to commercialization, including feasibility, development projects, product launches, design transfers, site enablement and commercial supply. The incumbent coordinates Product development and transfer activities with Lab Operations, Supply Chain, Client Services, Clinical Bioinformatics Operations, Quality Assurance, Regulatory Assurance, Pathology, Technology and Product Development teams.

Requirements

Bachelor's degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) and 10+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background; OR Master's degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.) and 8+ years related operations experience in a leadership role; Pharmaceutical/Healthcare Industry background;
6+ years of experience in Next Generation Sequencing with an emphasize on data and analytics
5+ years of proven leadership experience
Demonstrated deep understanding of FDA and CAP/CLIA regulations

Nice To Haves

Master's degree in relevant technical field (chemistry, molecular biology, bioinformatics etc.)
Applied knowledge of product development processes with familiarity in the design control process
Ability to manage conflict and encourage collaboration, and successfully implement change
Demonstrated competencies in team leadership, team facilitation, and team member participation
Demonstrated ability to engage and deliver through indirect staff across many departments, countries, and cultures
Ability to deliver in a complex global organization
Strong communication skills (oral and written) with the ability to present at the functional and executive levels
Understanding of HIPAA and importance of privacy of patient data
Commitment to FMI values: Integrity, Courage, and Passion

Responsibilities

Primary operations representation in the Product organization.
Represents operations interests in the planning, development, and launch of new products.
Ensures alignment of Product and Global Operations goals - and proactively manages conflicts and trade-off decisions when they occur.
Develops and implements robust and scalable Design Transfer and Site Enablement policies and procedures.
Ensures Design Transfer activities are completed in accordance with Stage Gate deliverables.
Coordinates with Site Heads and functional SMEs to ensure all Site Enablement activities are completed.
Ensures the compliance to regulatory (e.g. GMP) and legal requirements (occupational health and safety as well as protection of the environment) and represents the interests of Operations with internal and external parties.
Assists in development of and assures execution of strategic and operational plans for assigned Product groups.
Provides accurate and timely financial / budget information to ensure fact-based portfolio management and resource utilization.
Ensures that optimization processes in Global Operations are continuously pushed forward and implemented.
Manage, mentor, and coach a technically skilled team with varying levels of experience.
Travel up to 30% of the time.
Other duties as assigned.