Companion Diagnostic Lead

Takeda Pharmaceutical Company • Boston, MA

431d • Remote

About The Position

The Companion Diagnostic Lead at Takeda is a pivotal role within the Precision and Translational Medicine function, focusing on the development and execution of companion diagnostic strategies for early-stage oncology programs. This position involves leading cross-functional teams, interfacing with internal stakeholders and external partners, and supporting regulatory submissions, all aimed at enhancing patient outcomes through innovative diagnostic solutions.

Requirements

• PhD in cancer biology, genetics, molecular biology, pathology, or related field with 3+ years of experience, or MS with 5+ years of experience in the pharmaceutical, biotech, or diagnostic industry.
• Oncology experience is required.
• Experience in developing and delivering companion diagnostic work plans and supporting regulatory submissions.
• Successful track record in leading CDx/in vitro diagnostics development programs.
• Experience with diagnostic submissions to international health authorities is desired.
• Experience working with external diagnostic partners is required.
• Precision medicine strategy development experience is essential.
• Knowledge of histopathology and other technology platforms (PCR, genomic, immunoassays) is desirable.
• Experience collaborating with drug development teams to understand diagnostic needs.

Nice To Haves

• Understanding of medical device and clinical laboratory requirements.

Responsibilities

• Lead cross-functional teams to develop and implement diagnostic strategies for oncology programs.
• Drive technical assessment of assay/device analytical and clinical validation.
• Identify and negotiate with companion diagnostic partners, ensuring high-quality work plans and data packages.
• Collaborate with external diagnostic partners to develop, file, and launch CDx/devices globally.
• Support business development initiatives and due diligence teams.
• Contribute to the development of global diagnostic regulatory submissions and respond to health authority inquiries.
• Act as a scientific and technical thought leader for diagnostic development and commercialization.

Benefits

• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Sick time and paid vacation accrual.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Ph.D. or professional degree