Clinical Product Manager

The Clinical Product Manager is responsible for the development, implementation and maintenance of clinical trial solutions to support and differentiate Foundation Medicine’s offerings as it relates to our support and conduct of clinical trials.

Individuals in this role are responsible for leading the continued evolution and maintenance of the current FoundationSmartTrialsTM offerings, including patient matching and clinical trial site identification, and for identifying and launching new solutions, services or partnerships to maximize our current offerings in support of clinical trials and Profiling Studies.

This position manages a product or service, including design and implementation, leading operational execution, and management of continuous improvement and process and system optimization.

Additionally, this role supports Clinical Operations and Data Management Strategic Projects as it relates to competitive market intelligence and future Clinical Trial offerings.

Key Responsibilities

Function as Clinical Product Lead for Clinical Trial Solutions:

• Be responsible for the identification of high priority solutions based on market and industry intelligence as it relates to specific focus areas within Oncology Clinical Trials and NGS in order to differentiate FMI’s offerings to support FMI and Profiling Studies.
• Lead cross-functional buy/build/partner analysis with appropriate internal stakeholders with support from a supervisor and gain endorsement of offering from BioPharma and ClinOps/Data Management LT.
• Once offering is selected, lead the product or offering strategy including the design, development, implementation and optimization of offerings; this includes the development and delivery of processes and procedures to support execution of the offering, and defining requirements for supporting technology systems, tools, and templates.
• Coordinate the prioritization and delivery of product requirements to Technology Product Development team as needed.
• Partner with BioPharma and Product Marketing to define the value and set pricing for the offering, develop external collateral and marketing material to use in BioPharma sales pitches and on FMI website, develop internal sales support collateral, and participate as an SME on offering in external Partner pitches and proposal development.
• Define launch strategy and be responsible for delivery of offering to Partner, including training of internal and contract staff on offering.
• Manage offering implementation and operational activities, including resource identification and allocation.
• Support Partner calls and act as primary liaison with FMI Finance to reconcile and approve Partner invoices.
• Establish Key Performance Indicators to measure not only the success of the offering, including market penetration, but also optimization of the process or system solution to enhance the offering.
• Proactively identify risks and opportunities for added efficiency in process, technology, and resource allocation.
• Perform periodic executive reports/dashboards on offerings to highlight customer success and challenges, and communication of offering improvements.
• Establish effective partnerships with stakeholders in BioPharma, Technology, Commercial, Compliance, Corporate Development & Strategy, and peer partners within Clinical Operations and Data Management.

Support Partnership Discussions with Clinical Trial Solution Providers:

• Work with Corporate Development to identify Partnership opportunities to further maximize product/offering.
• Lead discussions with potential Partners.
• Present to BioPharma and Clinical Operations and Data Management Leadership potential engagements, support Legal and Corporate Development on contracting, and work with Corporate Communications on external communications.

Competitive/Market intelligence on changes and new offering in Clinical Trial space:

• Partner with FMI’s Strategic Insights and Analytics team to identify offerings/products from competitive industry peers.
• Obtain industry trends in Clinical Trial conduct and Oncology research to develop new offerings or enhancements to current solutions.
• Conduct research in collaboration with external-facing colleagues to understand unmet customer needs at Partner, Investigator and Patient level.

Support Strategic Projects/Initiatives as needed:

• Lead other strategic projects or initiatives as prioritized by Clinical Operations and Data Management, including business case development and initial project management support

Provide Project Management support:

• Provide planning and coordination for goals/initiatives from development to deployment of deliverables.
• Perform ongoing project risk and issues assessments and critical dependencies analysis, communicating with team members and with goal/initiative leader as appropriate.
• Develop, distribute, and maintain key team documentation to support project.

Provide Communication and Change Management support:

• Use core communication and Change Management methodologies to support delivery of internal and external communication efforts.
• Ensure that communications meet their objectives by establishing and incorporating communications methodologies assessments.
• Ensure communications and Change Management timelines are prioritized in alignment with department and stakeholder business needs.

Other duties as assigned.

Qualifications

Basic Qualifications

• Bachelor’s degree in a scientific field or equivalent combination of education, training and experience

• 4+ years of experience in product or project management in Life Sciences

Preferred Qualifications

• Masters or Advanced Degree in a business or scientific discipline

• Proven work experience in product or project management, especially in the pharmaceutical or diagnostic industry or a comparable position in clinical trials

• Experience working in a cross-functional environment, especially in a leadership capacity

• Experience in business process management

• Experience of Change and Communication Management

• Strong clinical trial knowledge or experience, especially in oncology

• Knowledge of clinical trial regulatory requirements and how these requirements relate to the drug development process

• Proficiency with use of applications and collaborative tools

• Familiarity with process & training management e.g., process mapping, documentation, training systems

• Knowledge and understanding of GCP regulatory requirements, patient privacy standards as well as knowledge of medical and pharmaceutical terminology

• Ability to manage all aspects of a successful product and project throughout its lifecycle

• Detail-oriented with the ability to prioritize, organize, plan and manage multiple tasks efficiently and complete task assignments independently

• Ability to work in a team/oriented environment and establishing and maintaining effective work relationships with co-workers within and across a matrix organization

• Strong verbal and written interpersonal and communication skills

• Understanding of HIPAA and the importance of patient data privacy

• Commitment to reflect FMI’s values: Patients, Passion, Innovation, and Collaboration

LI
– Remote [Cambridge, Massachusetts, United States] 

Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location.

Accommodations may be made in accordance with applicable law.

About Foundation Medicine

Foundation Medicine, Inc.

(FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care.

Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies.

Foundation Medicine is the culmination of talented people coming together to realize an important vision, and  the work we do every day impacts real lives.

Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us.

At Foundation Medicine theres no such thing as the perfect applicant, and our  company is a place where every employee can make an impact  and continue to grow whatever background they may have or path they may have taken.

So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.