About the Job

The Associate Director, Lifecycle Product Development leads the product development strategy and implementation of a designated product or portion of the clinical product portfolio at the direction of the Portfolio Lifecycle Development lead. The position is responsible for directing the strategy, ideation, releases and features of the designated product(s) and their respective workflows, in close collaboration with departmental and cross-functional stakeholders. This includes supporting regulatory submissions while ensuring compliance to design control and design change principles. Additionally, this position may be responsible for mentoring and training some staff within the department.

Key Responsibilities

• Strategy Implementation:
  • Contribute to strategic roadmap for developing FMI’s product and molecular information portfolio.
  • Partner with leaders and colleagues across Product Development, Computational Biology, Technology, Clinical Development, Operations, Commercial and Biopharma to refine the roadmap as defined on a monthly, quarterly, and annual basis.
  • Provide structured thinking to product team on overall product development including negotiation of scope, roles and responsibilities, specifications, timelines, and resources.
• Product Development:
  • Provide cross-functional leadership, technical oversight, and accountability
  • Lead the team to identify/manage key project risks; develop innovative and feasible de-risking strategies
  • Lead design stage reviews that demonstrate technical performance and achievement of key milestones
  • Assimilate market data and information on client and customer groups gathered by Commercial, Clinical and Biopharma groups into requirements for new products and existing product improvements.
  • Conduct brainstorms and other sessions to curate new ideas for product development, incorporating feedback and information from external innovation in the field.
  • Schedule and lead meetings and/or events with the purpose of driving technical decisions and cross-functional alignment, fostering team ownership and commitment to technical development plans from Feasibility to Launch stage
  • Incorporate new information into the product roadmap as identified.
  • Produce reports and information for product development stages for assigned projects.
  • Work closely with the regulatory team to help define strategy for and execute on product launches across multiple geographies/regulatory authorities
• Other:
• Provide direct support to Biopharma partners by communicating technical capabilities in face-to-face meetings, conference calls, and other forms of communication
• Act as point of contact for team in cross-functional communications, and additionally act as liaison between the team and FMI governance (the Portfolio Review Team, Infrastructure Management Team, and the Executive Team).
• Generate communications related to program and product plan activities, progress, milestones, obstacles, and plans.
• Develop and maintain in-depth technical/troubleshooting knowledge regarding the designated product(s).
• Rapidly resolve critical issues that impact delivery
• Other duties assigned

Qualifications:

Basic Qualifications:

• Master’s Degree in Molecular Biology, Genetics, Computational Biology or a related life sciences field
• 7 years of experience within the biotechnology or life sciences industry

Preferred Qualifications:

• PhD in Molecular Biology, Genetics, Computational Biology or a related field
• Established knowledge base regarding NGS technology and biomarker development
• 3 years of prior work experience in cancer diagnostics
• 3 years of prior experience developing and overseeing the execution of development programs that have led to long-term, sustainable success of multiple products
• Detailed knowledge of clinical product development, including:
• Regulatory data and processes
• Interpretation of complex data sets (scientific, business, and financial), clinical trial designs and scientific or clinical publications
• Expertise in building relationships based on trust both internal and external to an organization
• Proficiency in Excel and PowerPoint
• Technical proficiency and creativity
• Strong capacity for independent thinking
• Excellent verbal and written communication skills, specifically presentations
• Ability to explain complex technical details in clear language
• Ability to work independently as well as part of a team.
• Understanding of HIPAA and importance of patient data privacy
• Commitment to reflect FMI’s Values: Patients, Passion, Collaboration, and Innovation

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