Director, Bioanalytical Sciences - Immunogenicity

Key Skills

Java Programming, Python Programming, C++, C Programming, SQL, Cloud computing, Scala Programming, Machine learning techniques, Data science techniques, MATLAB Programming, PyTorch, TensorFlow, R Programming

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Bioanalytical Sciences - Immunogenicity 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 Director, Bioanalytical Sciences Immunogenicity working on the Clinical Biomarker Innovation & Development team, you will be empowered to drive its clinical immunogenicity efforts, provide strategic, technical, and regulatory expertise and influence and inspire scientists. A typical day will include:

POSITION OBJECTIVES:

• The Clinical Biomarker Innovation & Development department at Takeda is seeking a strong scientific and strategic leader to join its Bioanalytical Sciences (BAS) group and drive its clinical immunogenicity efforts for development and approval/post-approval of novel therapeutics across the range of modalities (small molecules, antibodies, nucleic acid, cell & gene therapies) in Oncology, Neuroscience, Gastroenterology, Immuno-oncology, and Rare Diseases therapeutic areas.
• With an increase in complexity, diversity and size of our portfolio, we expect the candidate to provide strategic, technical, and regulatory expertise in immunogenicity area, as well as to have a broad experience in all aspects of bioanalytical sciences, biomarkers and diagnostics. An important requirement is the ability to identify and leverage cutting-edge technologies that can significantly impact clinical drug development decisions and bring value to patients and prescribers.
• The Director will also be a 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.

POSITION ACCOUNTABILITIES:

• Serve as a key member of the BAS leadership team.
• Subject matter expert for immunogenicity assessment and mitigation strategies
• Drive, develop and oversee execution of immunogenicity strategy and plans across Takeda portfolio.
• Accountable for development and validation of immunogenicity assays, sample analyses, data interpretation and delivery of immunogenicity results and reports.
• Oversee CRO labs to assure highest quality of the data and adherence to the project timelines and budgets.
• Contribute to and author relevant regulatory submission document (pre-IND, IND, IB, BLA, etc.)
• Represent BAS and CBID at internal scientific reviews and governance meetings, external forums, consortia and health authority interactions.
• Build relationships & collaborate with scientific leaders, KOLs, academic partners, CROs, and health authorities
• Coach and guide staff on scientific concepts and technical details of immunogenicity and various bioanalytical methodologies. Play a major role in developing and maintaining a culture that is innovative, encourages risk, and supports the development of its people

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• A PhD or MD/PhD in pharmacology, immunology or related discipline with at least 12 years of post-doctoral experience with significant tenure in the industry
• A 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.
• Strong scientific background and experience with clinical immunology, immunogenicity, bioanalytical assay development and validation.
• Subject matter expert in analytical platforms such as ligand-binding assays, LC-MS/MS, Elispot, electrochemiluminescence, companion diagnostics, genomic analysis, etc.
• Capable of applying the highest scientific and technical standards for the successful design and execution of clinical bioanalytical assays implemented from early to late-stage clinical programs.
• Strong communication skills; ability to influence and inspire, preferably experienced in navigating and influencing large, highly complex, global matrixed environments.
• Experience in mentoring scientists, and a proven ability to build effective teams
• Broad and strong network in the industry, biotech, and health authorities.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

TRAVEL REQUIREMENTS:

• 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