Job Description

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 Bioanalytical Sciences 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 Bioanalytical Sciences - Chemistry working in the Clinical Biomarkers Innovation and Development (CBID) organization, you will be empowered to oversee bioanalytical chemistry support for several clinical programs, and contribute to biomarker evaluation using mass spectrometry approaches. A typical day will include:

POSITION OBJECTIVES:

Execute or supervise bioanalytical chemistry support for multiple compounds, ensuring that projects are completed in a timely manner, meet current scientific and quality standards, and adequately support planned global regulatory submissions.
Scope of responsibility focused on development of analytical strategy and implementation for LC/MS-based large/small molecule PK and biomarker method development, transfer, and validation activities at qualified vendors, also responsible for coordination of sample analyses at bioanalytical vendors, monitoring bioanalytical vendors to ensure quality, assay results, and bioanalytical reports. 
Identification and implementation of cutting-edge LC/MS-based approaches for impactful core deliverable expansion.
Responsible for providing strategic input and scientific expertise to global project teams on all issues relevant to bioanalytical chemistry.
Independently manage and resolve any problems or issues relevant to bioanalytical chemistry while keeping manager informed of critical issues in a timely manner.

POSITION ACCOUNTABILITIES:

Developing and implementing the bioanalytical chemistry strategy for multiple global development programs, including vendor selection and oversight of assay development or transfer.
Supports Phase 1-4 and post-approval clinical studies by providing input during synopsis and protocol preparation, coordinating sample shipment from clinical sites, and overseeing sample analyses at the bioanalytical vendor,
Providing scientific and technical oversight to the bioanalytical vendor during method development, transfer, validation, or production (including on-site audit of data).
Preliminary and final assay results and working with the project scientists to ensure that appropriate re-assays are conducted
Provides scientific expertise to relevant scientists for trouble-shooting bioanalytical issues in clinical studies.
Ensuring final assay reports are complete and accurate and meet regulatory filing requirements.
Provides input to appropriate sections of clinical study reports (CSR).
Preparing and/or providing input on regulatory documents including: Investigational New Drug Applications (IND), Regulatory Briefing Documents, Investigational Brochures (IB), Investigational Medicinal Product Dossiers (IMPD), Common Technical Documents (CTD) as the basis for New Drug Applications (NDA, BLA) in the U.S. and Market Authorization Applications (MAA) in the EU, IND annual reports, EMA/CHMP documents, and scientific white papers.
Represent Takeda at external meetings and conferences as well as establish the reputation of Takeda with key opinion leaders, practitioners, partners and agents, and the public at large.
Collaboratively interact with scientists from other functional areas in TGRD-US, as well as from other Takeda divisions, affiliates, and alliance partners.
Identify and recommend improvements to departmental processes.
Lead scientific due diligence to assess cutting-edge technologies and establish external partnerships as needed.
Oversee plans for technical on-site visits of external laboratories responsible for testing clinical bioanalytical samples.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Ph.D. degree in Chemistry, Biochemistry or related area with minimum 10 years of bioanalytical chemistry or other relevant experience; M.S. degree with minimum 14 years of bioanalytical chemistry or other relevant experience
Significant drug development experience from a bioanalytical chemistry perspective is required.
Demonstrate a sustained record of scientific productivity and innovation in the field of bioanalytical chemistry, as evidenced by the development and/or implementation of numerous new technical strategies, methods, processes, publications, or patents.
In depth, expert knowledge of bioanalytical chemistry, including HPLC, ligand binding and mass spectrometry analysis techniques.
Strong knowledge of allied fields critical for drug development, such as drug metabolism, pharmacology, toxicology, and pharmaceutical science is expected.
Thorough understanding of drug development and global regulatory requirements.
Excellent oral and written communication skills, including writing, reviewing, and editing scientific documents.
Ability to be an effective member of multi-disciplinary project teams.

This job posting exclude Colorado applicants.

TRAVEL REQUIREMENTS:

Some domestic and international travel to Takeda sites, bioanalysis 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.

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