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Scientific Manager, Scientist I, Biomarker Science & Technologies - Innovative biopharmaceutical res

Employer
Takeda Pharmaceutical
Location
Cambridgeport, Massachusetts, US
Salary
Competitive
Closing date
Jan 24, 2025
View more categoriesView less categories
Sector
Academic / Research
Field
Conservation science
Discipline
Project Management
Salary Type
Salary
Employment Type
Full time
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## **Job Description**

# About the role:

At Takeda, we are a forward-looking, world-class R&D; organization that
unlocks innovation and delivers transformative therapies to patients. By
focusing R&D; efforts on four therapeutic areas and other targeted
investments, we push the boundaries of what is possible in order to bring
life-changing therapies to patients worldwide.

The Scientific Manager, Scientist I, Biomarker Science & Technologies is an
exciting, high impact role within the Biomarker Science and Technologies (BST)
department within Preclinical and Translational Sciences (PTS) at Takeda. You
will work with stakeholders within BST, PTS, and with partners across the
business including Clinical Pharmacology, Clinical Operations, Procurement,
R&D; and IT Quality, and Clinical Data Solutions to support clinical
bioanalytical and biomarker scientific operations and logistics with external
vendors thereby helping create high quality clinical data.

# How you will contribute:

* The scientific manager will be accountable for project management and process-related strategies and deliverables for the BST sub-team and will work closely with the BST sub-team leader.

* The incumbent will oversee operational deliverables for different therapeutic modalities across the Takeda portfolio.

* Candidate will work in close partnership with the clinical biomarker, diagnostics, and bioanalytical sciences groups within BST.

* The position also requires working in close partnership across various Takeda functions including Translational Sciences within each Drug Discovery Unit, Clinical Operations, Data Sciences, Legal, Finance and Quality Assurance.

* Experience managing multiple biomarker deliverables for concurrent clinical trials.

* Success in these responsibilities requires an understanding of disease biology, strategic thinking, attention to detail, and experience in drug development.

* A working knowledge of various analytical methods including ligand binding assays, LCMS, qPCR, flow cytometry and immunohistochemistry as well as a working knowledge of fit-for-purpose assay rigor (qualification, validation, etc) requirements needed to support clinical endpoints would be beneficial for success in role.

* Coordinate assigned studies and programs by planning for and managing timelines for various deliverables and facilitate communication between BST scientists and CRO labs as well as negotiate and ensure all high priority timelines for data delivery and reports are met.

* Contributes to bioanalytical and biomarker outsourcing strategy, vendor oversight and manages priorities and study timelines for activities performed within CRO partnership agreements.

* Partner with BST colleagues to develop efficient processes for execution of bioanalytical and biomarker activities.

* Solid understanding of Quality Assurance requirements to ensure vendor compliance and data integrity.

* Support BST efforts to build effective and strategic relationships with QA&C;, clinical operations, and other key functions within Takeda.

# Minimum RequirementsQualifications:

* PhD degree in a scientific discipline, or MS with 6**+** years experience, or BS with 8**+** years experience

* Knowledge of drug development, clinical trial principles and understanding of the role of bioanalysis and biomarkers in clinical studies.

* Experience in sample management activities across multiple projects.

* Ability to work with a diverse group of scientists, clinicians, vendor labs, and a variety of internal and external team players to support product strategy.

* Excellent written, organizational, and interpersonal communications skills in order to efficiently and succinctly update the stakeholders and internal team members on progress, address questions and issues as well as interface with external vendors.

* Working knowledge of FDA & ICHGCP regulations and clinical laboratory specimen handling. Knowledge of regulations from other regions (e.g., China and Brazil) a plus.

* Experience with Labmatrix or equivalent sample management software is a plus.

* Proven critical reasoning skills including the identification and resolution of complex problems.

# More About Us:

At Takeda, we are transforming patient care through the development of novel
specialty pharmaceuticals and best in class patient support programs. Takeda
is a patient-focused company that will inspire and empower you to grow through
life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers,
encourages innovation, and strives for excellence in everything we do. We
foster an inclusive, collaborative workplace, in which our teams are united by
an unwavering commitment to deliver Better Health and a Brighter Future to
people around the world.

This position is currently classified as hybrid in accordance with Takedas
Hybrid and Remote Work policy.

**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:**

108,500.00 - 170,500.00

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 andor 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_**

_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._

## **Locations**

Boston, MA

## **Worker Type**

Employee

## **Worker Sub-Type**

Regular

## **Time Type**

Full time

**Job Exempt**

Yes

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