Hiring company: Takeda
Senior Scientist Clinical Biomarker, Immunology
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, Immunology in our Cambridge, MA or San Diego, CA 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 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.
POSITION OBJECTIVES:
- 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 programs for Rare Diseases, specifically Rare Immunology and Genetics indications, with the opportunity to support different therapeutic modalities across Neuroscience and Gastroenterology.
- Provide immunology expertise across a variety of programs to shape biomarker and clinical development strategies and leverage appropriate technologies to address project needs.
- 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
POSITION ACCOUNTABILITIES:
- 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.
- 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, KOLs, academic partners, CROs and health authorities.
- Knowledge of current drug development tools, e.g. FDA BEST and attention to innovation and improvement of current practices.
- 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 immunology or related life scientific discipline with a minimum of 5 years of biotech/pharma industry or academic experience post PhD. Preference will be given to applicants with experience with immunology.
- A productive track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
- Experience with gene therapy and/or mAb modalities and a strong understanding of the development and regulatory hurdles inherent in these technologies is desirable but not required.
- 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.
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.
*LI-RM
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.