BST and Clinical Biomarker Lead, Neuroscience, Associate Director
Takeda Pharmaceutical Company Limited
This job is no longer accepting applications
See open jobs at Takeda Pharmaceutical Company Limited.See open jobs similar to "BST and Clinical Biomarker Lead, Neuroscience, Associate Director" Greatness.bio.BST and Clinical Biomarker Lead, Neuroscience, Associate Director
Boston, Massachusetts- 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.
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’sPrivacy Noticeand 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
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 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 levels
Innovation
- Makes strategic recommendations for relevant biomarker technologies and outputs in alignment with stakeholders.
Complexity
- Highly-matrixed environment
Education & 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 partnership
This position is currently classified as “hybrid” by Takeda’s 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, 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-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
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, MAWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeWhere 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
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.
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.
Related Content
- Global Top Employer 2024 Takeda named Global Top Employer for seventh consecutive year.
- Accelerating Next-Generation Cell Therapies Explore more.
- Working Here Explore more.
Jobs for you
- Associate Director, Process Design & Improvement Boston, Massachusetts Category: Project/Program Management
- Director: Cell Therapy Discovery Core Portfolio Lead, ODDU Boston, Massachusetts Category: Pharmaceutical Sciences
- Senior JavaScript Engineer - Digital Product Development Boston, Massachusetts Category: Pharmaceutical Sciences
- Senior Scientist, Systems Biology Boston, Massachusetts Category: Research Science
About our location
Join our talent community
Get customized job alerts sent right to your inbox. Plus, get the latest in company news and other important resources by signing up for our talent community.
This job is no longer accepting applications
See open jobs at Takeda Pharmaceutical Company Limited.See open jobs similar to "BST and Clinical Biomarker Lead, Neuroscience, Associate Director" Greatness.bio.