Head of Oncology Companion Diagnostics

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES: 

The Head of Oncology Companion Diagnostics (CDx) is an exciting new opportunity within the growing Precision and Translational Medicine (TPM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda.  The primary focus of this role will be to lead the R&D efforts for all Oncology companion and complementary diagnostics, including follow-on diagnostics, needed to advance Takeda’s promising Oncology pipeline through development, launch and post-marketing. Key responsibilities include mapping CDx needs for Takeda’s Oncology pipeline programs (including cell therapy), driving innovation in diagnostic development, identifying suitable external diagnostic partners, participating in partnership negotiations, leading the development and delivery of diagnostic workplans, participating in health authority meetings and regulatory submissions (PMAs etc), participating in external diagnostic consortia.  This role will partner closely with key functions across Takeda Oncology including Business Development, Translational Medicine, Clinical, Global Regulatory Affairs, the Oncology Business Unit (Commercial and Medical Affairs), Alliance Management, and clinical biomarker technologies.

The level of the position will be determined based on the skills and experience of the candidate.

ACCOUNTABILITIES: 

• Develop and deliver an overarching Oncology Diagnostic strategy for Takeda, including mapping potential diagnostics needs for the Oncology and Cell Therapy pipeline
• Identify innovative companion diagnostic partners, contribute to partnership negotiations, ensure the development of high quality work plans and data packages for companion diagnostics, complementary diagnostics and follow-on diagnostics
• Contribute to the development of global diagnostic regulatory submissions, respond to health authority questions, review labeling documents
• Function as a scientific R&D thought leader at Takeda for diagnostic development and commercialization

EDUCATION AND EXPERIENCE

• PhD or MD in cancer biology, genetics, molecular biology, pathology or related field with 8+ year’s experience or an MS with 14+ years of experience in pharmaceutical or biotech R&D
• Oncology experience required
• Experience in developing and delivering companion diagnostic work plans, data packages, and PMA submissions
• Experience leading in vitro diagnostics (IVD) development and implementation in clinical studies
• Experience with diagnostic submissions with international health authorities desired
• Experience identifying and leading partnerships with external diagnostic partners required
• Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans

SKILLS

• Excellent communication (written and oral) skills
• Excellent strategic, interpersonal, influence, and negotiating skills
• Demonstrated ability to work effectively across functions, projects, and time zones and with external partners
• Ability to assemble and motivate cross functional stakeholders and drive results
• Ability to proactively predict issues and solve problems with agility
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Ability to drive multiple priorities forward simultaneously

KNOWLEDGE

• Advanced knowledge of diagnostic development including analytic and clinical validation, drug development,  oncology therapeutic area, precision medicine approaches in clinical development.

TRAVEL REQUIREMENTS:

• Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be required
• Requires approximately 15 - 20% travel

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

This job posting excludes CO applicants

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