Companion Diagnostic Lead
Company: Takeda Pharmaceutical
Location: Boston
Posted on: November 12, 2024
Job Description:
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 DescriptionAre 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 commercializationEDUCATION
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
desiredSKILLS
- 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
simultaneouslyKNOWLEDGE
- 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
requirementsTRAVEL REQUIREMENTS:
- Ability to drive to or travel to conferences, partner meetings,
including overnight trips. Some international travel may be
required
- Requires approximately 10 - 15% travelTakeda 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 lawThis position is currently
classified as "hybrid" in accordance with Takeda's Hybrid and
Remote Work policy. -#LI-JT1Takeda Compensation and Benefits
SummaryWe 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, MAU.S.
Base Salary Range:149,100.00 - 234,300.00The 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 StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeJob
ExemptYes
Keywords: Takeda Pharmaceutical, Medford , Companion Diagnostic Lead, Other , Boston, Massachusetts
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