POSITION SUMMARY: 

The VP of Molecular Diagnostic Development is primarily responsible for leading IVD assay development and biostatistics within oncology division of Invitae. As a part of these functions the VP of Molecular Diagnostic Development will work closely with product management, clinical operations, regulatory, software, operations and other teams to ensure successful execution of the oncology diagnostic strategy. The successful candidate must possess a deep understanding of regulated product development, design control, NGS, and the broader CDx landscape. This leader will mentor and support the IVD assay development and biostatistics teams and encourage a collaborative environment with all cross-functional teams. This leader will also interface with regulatory agencies, external partners, and internal teams to ensure on-time regulatory submissions and successful development of IVDs and clinical trial assays.

RESPONSIBILITIES:

Job performance will involve a variety of activities including:

• Developing and establishing diagnostic strategy and implementation
• Develop and retain highly skilled and effective scientists and biostatisticians
• Strategically partner with Quality, Clinical Operations/Development, Regulatory, and other areas on the design and execution of robust diagnostic development plans
• Leverage advances in the field and employ innovative methodologies in regulated diagnostics development
• Develop a thorough understanding of the diagnostic products to best position Invitae as a leader in advanced molecular diagnostics
• Identify and implement opportunities for improvement in diagnostic development and system architecture
• Clear and effective communication to company leadership on development progress and resourcing needs
• Remains current with business trends, internal and external
• Remains current with industry and regulatory trends and their potential impact on ArcherDX programs
• Reviews and adheres to ArcherDX HIPAA Security policies and procedures.

EXPERIENCE:

• 10+ years of regulated diagnostic development
• Successful and proven track record of developing LDTs, IVDs and/or Clinical trial Assays
• Deep understanding of diagnostic development and biostatistics methodologies and their interdependencies
• Experience managing teams of highly skilled scientists and biostatisticians
• Experience building effective teams and manage conflict
• Experience leading and working collaboratively on cross-functional project teams
• Effective at attracting and developing talent to build a highly effective function.
• Willing to lead, act as a player-coach and roll up his/her sleeves and do what is necessary to meet project and corporate goals
• Excellent verbal and written communication and presentation skills Excellent project management skills

KEY ATTRIBUTES:

• Strong desire to make a positive impact in the treatment of cancer patients
• Drive and determination
• Ability to work in a fast paced and dynamic environment
• Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
• Strong communication and presentation skills
• Self-starter

EDUCATION:

• PhD or equivalent experience in biological sciences, genetics, biochemistry or a related field.