Companion Diagnostic Lead

Boston, Massachusetts

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Job Level: Senior
Travel: Minimal (if any)

At Takeda, we strive to provide transformational opportunities for every member of our team, and we empower our people to take charge of their futures. In an environment that fosters lifelong learning and a growth mindset, you’ll have the support you need to thrive — at work and beyond.

Job ID R0134268 Date posted 09/13/2024 Location Boston, Massachusetts

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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? Join us as a Companion Diagnostic Lead in our Cambridge office.

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 Oncology Companion Diagnostics (CDx) Lead role is an exciting new opportunity within the growing Precision and Translational Medicine (PTM) function in the Oncology Therapeutic Area Unit (OTAU) at Takeda. The primary focus of this role will be to lead the R&D efforts around CDx strategy development and execution for early-stage Oncology CDx programs. Key responsibilities include leading the development and delivery of diagnostic workplans, ensuring efficient and effective test development and deployment in a global clinical trial setting, interfacing with key internal stakeholders and external diagnostic partners, and supporting health authority meetings and regulatory submissions (PMAs etc). This role will partner closely with key functions across Takeda Oncology including Translational Medicine, Clinical, Sciences, Global Regulatory Affairs, the Oncology Business Unit (Commercial and Medical Affairs), Alliance Management, Business Development, and clinical biomarker technologies.

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

ACCOUNTABILITIES:

Lead cross-functional team to ensure effective development and implementation of diagnostic strategies supporting oncology programs, including follow-on and region-specific workstreams
Drive technical assessment of assay/device analytical and clinical validation
Identify appropriate companion diagnostic partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packages
Work with external diagnostic partners to develop, file, and launch CDx / devices globally in-alignment with therapeutic program development and commercial objectives
Support BD initiatives and due diligence teams
Contribute to the development of global diagnostic regulatory submissions, respond to health authority questions, and review labeling documents
Function as a scientific and technical R&D thought leader at Takeda for diagnostic development and commercialization

EDUCATION AND EXPERIENCE

PhD in cancer biology, genetics, molecular biology, pathology or related field with 3+ years of experience or a MS with 5+ years of experience in the pharmaceutical, biotech or diagnostic industry
Oncology experience required
Experience in developing and delivering companion diagnostic work plans, assessing assay/device validation data packages, and supporting regulatory submissions
Successful track record leading CDx / in vitro diagnostics (IVD) development programs
Experience with diagnostic submissions with international health authorities desired
Experience working with external diagnostic partners required
Precision medicine strategy development experience
Histopathology technical and landscape domain knowledge would be ideal, understanding of other technology platforms (PCR, genomic, immunoassays…etc) desirable
Experience working with drug development teams to understand diagnostic needs and develop strategic diagnostic plans desired

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
Capable of proactively predicting issues and solving 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.
Understanding of medical device and clinical laboratory requirements

TRAVEL REQUIREMENTS:

Ability to drive to or travel to conferences, partner meetings, including overnight trips. Some international travel may be required
Requires approximately 10 - 15% travel

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Boston, MA

U.S. Base Salary Range:

149,100.00 - 234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Locations

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

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Where you fit in

Our team at Takeda is tackling some of the most challenging problems in drug discovery and development. As the newest member of our Research team, you’ll conduct purposeful, meaningful work on groundbreaking modalities that may lead to breakthrough drugs.

With our deep investment in next-generation technologies, you’ll have the resources and support to do your best work. As a part of our team, you’ll connect with brilliant minds inside and outside of Takeda. We are committed to collaborating with academia and emerging biotech companies to expand our reach and impact in cell therapy, gene therapy and data sciences.

Our team’s wide-ranging expertise includes medicinal chemistry, genomics datasets, immunofluorescence, high content imaging, flow cytometry, transcriptional profiling, multi-step synthesis, multimodal genetics, pharmacokinetics and much more. Whatever area inspires you, your work will support the progression of an innovative, industry-leading discovery pipeline and make an impact that matters to patients and society.

A career in Research at Takeda will give you everything you need to succeed professionally — and make a difference to patients, people and the planet.

Design and carry out experiments
Manage multiple projects
Document data
Mentor other scientists

Along with incredibly passionate colleagues, there’s a clear commitment to invest in the best facilities and the right equipment needed to successfully perform world-class science.

Christina Alves - Head of Biotherapeutics Process Development

I feel especially lucky to be able to work with colleagues across the industry to meet a unified goal.Takeda is paving the way for how research will be conducted in the future.

Daniel Scheibe - Senior Manager Operations, Systems Engineering, Drug Discovery Sciences

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

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What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

Integrity
Fairness
Honesty
Perseverance

Working at Takeda

Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top Workplace
Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives

Patient

Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People

Create an exceptional people experience.

Planet

Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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