Companion Diagnostic Lead

Bio-Life Plasma, LLC

Boston, MA

LOCATION

Third Shift

SHIFT

Job Description

As posted by the hiring company

Job Overview:

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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-term incentives. 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