BST and Clinical Biomarker Lead, Neuroscience, Associate Director
Company: Takeda Pharmaceutical
Location: Boston
Posted on: September 30, 2024
Job Description:
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application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAbout 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 three therapeutic areas and other
targeted investments, we push the boundaries of what is possible in
order to bring life-changing therapies to patients
worldwide.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.Are you looking for a
patient-focused, innovation-driven company that will inspire you
and empower you to shine? Join us as a BST and Clinical Biomarker
Lead, Neuroscience, Associate Director in our Cambridge, MA
location.Objective / Purpose:
- The Bioanalytical and Biomarker Science and Technologies (BST)
department at Takeda is seeking a strong scientific leader to join
the group as the BST lead to support programs within Neuroscience
Therapeutic Area across a range of modalities (e.g. small
molecules, antibodies, nucleic acids and more).
- BST Lead will support the clinical development of novel
therapeutics by developing translational and clinical biomarker
strategies for preclinical and clinical programs through cross
functional collaboration with NS Clinical Sciences, NS DDU,
Clinical Pharmacology, DMPK and others as well as external experts
in the field of Neuroscience
- BST Lead will also oversee implementation of biomarker and
bioanalytical strategies in clinical trials by working closely with
BST biomarker and bioanalytical SMEs, study logistics and BST
functional heads, and will monitor execution and ensure timely
fit-for-purpose assay development and validation at CROs and data
delivery to support decision making in clinical studies and
portfolio progression
- BST Lead will lead Translational and BST sub teams and will
collaborate cross-functionally to align on strategy and plans, and
assure effective delivery of data to clinical trials to support
decision making.Accountabilities:
- Responsible for developing and driving translational fluid and
tissue biomarker strategies for preclinical and clinical programs
within Neuroscience TA
- Actively leads collaborations with external clinical and
academic experts to support development of biomarker plans; stays
current on the state-of-the-art technologies and emerging biomarker
concepts
- Responsible for authoring biomarker and bioanalytical sections
of clinical documents (with input from BST SMEs), including study
protocols, regulatory documents and communications (IND, NDA, BLA,
PMA, etc.), Briefing Book (BB), Investigatory Brochure -(IB),
Clinical Study Reports (CSR), study start up (e.g. ICF, data
transfer agreements) and data base lock activities (e.g. sample
reconciliation, data review/QC and transfer), etc.
- Leads BST sub team of subject matter and logistical experts to
coordinate execution of BST deliverables to support clinical trials
in accordance with clinical study timelines
- Responsible for overseeing implementation of biomarker and
bioanalytical plans by working with BST sub team on vendor
selection and oversight, contract executions, timely assay
development and validation activities, and high-quality biomarker
and bioanalytical data delivery to clinical trials
- Represents BST at cross functional teams (GPT, CST, SET) and
keeps BST leadership informed of progress
- Collaborates cross functionally with Clinical Sciences, QCP,
Regulatory, DMPK, Research and other functions to support program
objectives
- Influences and inspires scientists in the organization, works
effectively in the matrix environment, and maintains a culture that
encourages innovation, scientific rigor, and growth
opportunities.DIMENSIONS AND ASPECTS Technical/Functional (Line)
Expertise
- Deep understanding of biomarker development and implementation
in neuroscience TA with 10+ years' experience in the biotechnology
or pharmaceutical environment.
- Solid understanding of bioanalytical and biomarker strategies,
applicable regulatory guidance, clinical trials, endpoints and
deliverables.Leadership
- The incumbent will serve as a subject matter expert on BST
teams helping drive scientific excellence, strategic, tactical and
fiscally responsible operations in support of BST and programmatic
goals.Decision-making and Autonomy
- Independently manages workload and expectations
- Scientifically independent
- Scientific driver for research strategy that impacts group
internally and outside area of function -Interaction
- Initiates and leads external interactions and
collaborations
- Frequent contact with internal and external personnel at
various management levelsInnovation
- Makes strategic recommendations for relevant biomarker
technologies and outputs in alignment with stakeholders.Complexity
- Highly-matrixed environmentEducation & Competencies
- PhD degree in a scientific discipline with 7+ years experience
, or MS with 13+ years experience, or BS with 15+ years
experience
- Extensive drug development experience, preferably in the
Neuroscience TA area
- Strong scientific background in biomarker development, various
biomarker technologies, experience with assay development and
validation, operational aspects and relevant regulatory
guidelines
- Excellent communication and collaboration skills; ability to
influence and inspire, preferably experienced in navigating and
influencing highly complex and matrixed environments.
- Enterprise mindset to enable effective delivery through strong
cross-functional partnershipThis position is currently classified
as "hybrid" by Takeda's Hybrid and Remote Work policyTakeda
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 time
Keywords: Takeda Pharmaceutical, Boston , BST and Clinical Biomarker Lead, Neuroscience, Associate Director, Executive , Boston, Massachusetts
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