About the Job

The Associate Director (AD), CDx Lead serves as the lead for companion diagnostic (CDx) development projects in collaboration with external biopharma partners. This requires leading and influencing a cross-functional, multi-disciplinary team in order to meet the requirements for successfully developing, validating, and launching new CDx indications within the existing Health Authority-approved, Foundation Medicine assays (e.g., FoundationOne®CDx (F1CDx) and FoundationOne®Liquid CDx (F1LCDx)).

As a member of the CDx Scoping team, the AD, CDx Lead provides leadership and technical oversight of pre-contract CDx project scoping and strategy. The AD, CDx Lead also helps develop detailed requirements and granular, end-to-end project plans to support completion of each contracted project including efforts to launch the new claim.

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.
• Develop and implements innovative and feasible de-risking strategies.
• 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.
• Serve as the primary contact for CDx project internal and external partners.
• Encourage creative ideas and problem solving and ensure that these are utilized by the team, as appropriate.
• Present development options, strategies, and recommendations to CDx Portfolio for endorsement at key decision points to allow fact based, transparent, and informed decision making.
• May perform other duties as required or assigned.

Qualifications:

Basic Qualifications:

• Masters in a science, engineering, or related technical field
• Masters 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 experience
• At least 3 years in a matrixed or multidisciplined team

Preferred Qualifications:

• Advanced degree (Ph.D.)
• Good understanding of Change Control process in a Regulated environment
• Experience with:
  • Projects that required activity/milestone achievement to launch the product.
  • External partner management
  • Leading diverse cross-functional project teams
  • Product design control in a regulated environment
  • Risk assessment and product requirement generation
  • IVDD/IVDR Product Development
• Diagnostic and/or Pharma industry and relevant diagnostic area knowledge
• Companion diagnostic and NGS experience
• Leadership skills in managing highly specialized multidisciplinary teams in a matrix environment
• Ability to resolve conflicts and adapt to change
• Ability to manage complex projects with ambitious milestones in a high-pressure environment
• Knowledge of market trends, technology trends, competitive landscape
• Excellent oral and written communication skills
• Strong organizational skills and attention to detail required
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMI's Values: Passion, Patients, Innovation, and Collaboration

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