Associate Director, Biospecimen Repository
Takeda fosters a collaborative and stimulating work environment filled with opportunity and the chance to make a difference in people's lives. It is a workplace driven by integrity, one of Takeda’s long-held values that extends to both the patients we serve and our employees who develop and deliver medicines. Across our company, Takeda employees bring together diverse strengths that together create a stronger whole.
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Associate Director, Biospecimen Repository
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Biospecimen Repository in our Cambridge, MA 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 an Associate Director, Biospecimen Repository working on the Clinical Biomarker Innovation and Development team, you will be empowered to establish a cutting-edge biospecimen library and biobank to drive biomarker science and precision medicine within CBID and across Takeda and serve as the CBID subject matter expert on reverse translation and be the point of contact for other functional areas within Research. A typical day will include:
- Establish a cutting-edge biospecimen library and biobank to drive biomarker science and precision medicine within CBID and across Takeda. We are looking for individuals with a passion for development of evidence-based standardized procedures for biospecimen science and research, and implementation of cross-functional processes and governance around re-use of existing and future clinical trial samples.
- Partner with the clinical biomarker, diagnostics and bioanalytical sciences groups within CBID, clinical science & operations, drug discovery & data science institute within Takeda, as well as external partners will be required to accomplish this compelling vision for the biobank repository.
- Oversee different therapeutic modalities across Oncology, Neuroscience, Gastroenterology, Immuno-oncology, and Rare Diseases. The successful candidate will have the opportunity to work closely with Clinical Operations, Translational Scientists, CROs and other KOLs to coordinate and manage the use of biospecimens in all Takeda clinical trials.
- Provide scientific and drug development expertise in all aspects of forward and reverse translation and influence precision medicine at Takeda. A solid understanding of disease biology, drug pharmacology, molecular pathways, clinical endpoints, clinical trial designs and diagnostics is essential. Ability and readiness to seek guidance when additional expertise is required is equally essential.
- Mentor and coach to the group. Success in this role will be evaluated by the ability to influence and inspire scientists in the organization, and maintain a culture that encourages innovation, scientific rigor, and growth opportunities.
- Provide guidance on international guidelines on biospecimen use and re-use, informed consent language and data privacy guidelines.
- Establish operational processes for the appropriate collection of biospecimens from clinical trials and vendors to support biomarker testing and companion diagnostic development.
- Track the collection, shipment and entry of samples into the repository. Manage the retrieval of samples from the repository and ensure chain of custody is maintained.
- Develop and update current informed consent and data transfer specifications by gathering input from stakeholders to ensure specimen use and future data reporting is consistent.
- Ensure review of study protocols, amendments, ICFs for sample/tissue collection, correspondence with the IRB and other study-related documents.
- Serve as the CBID subject matter expert on reverse translation and be the point of contact for other functional areas within Research. He/she will provide scientific collaboration and consultation with other Takeda stakeholders on how to utilize samples within the biospecimen repository to advance research efforts.
- The incumbent is expected to have scientific expertise in technology platforms relevant to biomarker testing and development, as represented by publications.
- Knowledge of international guidelines on biospecimen use and re-use, informed consent language and data privacy guidelines.
- 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
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- A PhD in immunology or related life scientific discipline with a minimum of 5 years of biotechnology or pharmaceutical industry experience or a MS with a minimum of 10 years’ experience.
- A productive track record of sustained, significant scientific contributions as demonstrated by publications, patents and presentations
- Extensive drug development experience preferably advancing several molecules from phase I to approval and supporting post-marketing/commercial activities. Experience in development of cell/gene-based therapies is desirable but not required.
- 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.
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
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Job ID R0021866