Associate Director, CDx Lead

Key Responsibilities

• Lead (3-5) CDx projects of varying complexity.
• Provide cross-functional leadership, technical oversight, and accountability and applies current CDx project strategy to CDx projects, from project scoping to initiation through launch, including analytical and clinical validation, regulatory submission(s), technology implementation, and CDx launch.
• Serve as the CDx Project Team Lead and partners with the CDx Project Manager to develop detailed requirements and strategies (e.g., novel biomarkers or redevelopment of assay features) for the end-to-end delivery of the CDx project.
• Ensure all team members and functions are aligned with the objectives of the team and project.
• Responsible for completion of each assigned CDx project on the associated timeline.
• Provide status updates and escalates emerging issues as needed.
• Lead the team to identify and manage key project risks.
• Create a positive team environment that instills trust and ensures clear communication, and unifies the team behind the overall goal/vision for the project.
• Motivate and inspires team to achieve challenging goals.
• Accountable for design control elements for each assigned CDx project.
• Provide direct support to Biopharma partners by communicating technical capabilities, CDx insight, and ownership of the portfolio device in external or face-to-face meetings, conference calls, and other forms of communication.
• Support other arms of the business as needed as a technical and subject matter expert for the given portfolio device.
• Drive best practices and implementation of lessons learned for optimal cross functional collaborations.
• May be a regular member of CDx Portfolio team, and participate in defining the CDx Development strategy and any process improvement activities.
• May be part of the CDx Scoping team, providing technical oversight and input on the pre-contract CDx project scope and develop strategy for development.
• Provide direct support to external partners by communicating technical capabilities insight on the CDx Portfolio.
• Participate in project and process improvement initiatives and change management across the CDx Portfolio, to drive the highest quality results.
• May perform other duties as required or assigned.

Qualifications

• Basic Qualifications: Masters in a science, engineering, or related technical fieldMasters with at least 8 years of experience in molecular diagnostics, medical device, or pharma industry experience, OR;Ph.D. with at least 4 years of experience in molecular diagnostics, medical device, or pharma industry experienceAt least 3 years in a matrixed or multidisciplined team
• Preferred Qualifications:Advanced degree (Ph.D.)Good understanding of Change Control process in a Regulated environmentExperience with:Projects that required activity/milestone achievement to launch the product.External partner managementLeading diverse cross-functional project teamsProduct design control in a regulated environmentRisk assessment and product requirement generationIVDD/IVDR Product DevelopmentDiagnostic and/or Pharma industry and relevant diagnostic area knowledgeCompanion diagnostic and NGS experienceLeadership skills in managing highly specialized multidisciplinary teams in a matrix environmentAbility to resolve conflicts and adapt to changeAbility to manage complex projects with ambitious milestones in a high-pressure environmentKnowledge of market trends, technology trends, competitive landscapeExcellent oral and written communication skillsStrong organizational skills and attention to detail requiredUnderstanding of HIPAA and the importance of patient data privacyCommitment to reflect FMI's Values: Integrity, Courage, and Passion

Pay

The expected salary range for this position based on the primary location of Remote is $156,000 - $195,000 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.