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Senior Scientist, Clinical Biomarker, Gene Therapy Programs
Senior Scientist, Clinical Biomarker, Gene Therapy Programs
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Scientist, Clinical Biomarker, Gene Therapy Programs 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.
As a Senior Scientist, Clinical Biomarker, Gene Therapy Programs working on the Clinical Biomarker team, you will be empowered to develop novel pharmacodynamic and diagnostic biomarkers that will impact clinical development paradigms and bring value to patients. A typical day will include:
- The clinical biomarker department at Takeda is seeking an outstanding scientist to develop novel pharmacodynamic and diagnostic biomarkers that will impact clinical development paradigms and bring value to patients.
- Oversee Gene Therapy programs for Rare Diseases, with the opportunity to support different therapeutic modalities across Oncology, Neuroscience, Gastroenterology and Immuno-oncology.
- Strong and compelling vision for driving biomarker science, its impact on drug development decisions, and supporting the development and commercial pipeline.
- Develop and leverage cutting-edge technologies that can significantly impact clinical drug development decisions.
- Provide scientific and drug development expertise in all aspects of biomarker sciences, including a deep understanding of disease biology, drug pharmacology, molecular pathways, clinical endpoints, clinical trial designs and diagnostics
- Establish their own laboratory and help train post-docs, junior scientists and interns.
- Influence and inspire scientists in the organization, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
- Build innovative biomarker strategies for the development and evaluation of relationships between clinical biomarkers (e.g., disease monitoring, pharmacodynamic/response, surrogate, safety) and PK/PD metrics including target occupancy, engagement, and physiological response in target tissue directly linked to pathophysiology.
- Contribute to Translational plans and lead clinical biomarker strategy and implementation. Represents the clinical biomarker department at team meetings, internal scientific reviews and governance meetings, and external forums and consortia and any health authority interactions.
- Drive, develop and oversee execution of clinical biomarker strategies and plans across different projects in the Takeda portfolio. Accountable for groups delivery of clinical biomarker results and reports.
- Build presence in external research community through publications and speaking engagements at conferences/academic institutions.
- Build relationships & collaborate with scientific leaders, academic partners, CROs and health authorities.
- Knowledge of current drug development tools, e.g. and attention to innovation and improvement of current practices.
- Identify, develop and implement companion diagnostic (CDx) strategies and assays to guide indication selection, patient enrichment and combination strategies.
- Provide technical and scientific leadership for assay development and validation studies to measure clinical biomarkers according to clinical context of use meeting clinical laboratory standards and regulatory requirements as applicable.
- Lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed.
- Play a major role in developing and maintaining a culture that is innovative, encourages risk, and supports the development of its people.
- Accountable for the achievement of critical goals that impact and contribute to the mission of Takeda.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- A PhD or MD/PhD in pharmacology, immunology or related life scientific discipline with a minimum of 5 years of biotech/pharma industry or academic experience post PhD.
- A productive track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
- Experience with gene therapy modalities (ie. AAV, AdV, ex vivo, etc) and a strong understanding of the development and regulatory hurdles inherent in these technologies.
- Extensive drug development experience preferably advancing several molecules from phase I to approval and supporting post-marketing/commercial activities.
- Strong scientific background and experience with clinical bioanalytical assay development and validation. Subject matter expert in analytical platforms such as flow/mass cytometry, next-generation sequencing, immunoassays, companion diagnostics, etc.
- Expert executive communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments with and without authority.
- Broad and strong network in the industry, biotech, CRO communities, and health authorities.
This job posting exclude Colorado applicants.
- Some domestic and international travel to Takeda sites, biomarker vendors, and regulatory agencies may be required.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Discover more at takedajobs.com
No Phone Calls or Recruiters Please.