Scientific Director, Research

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientific Director, Research, in our Cambridge, Massachusetts office.

Key Responsibilities:

• The Bioanalytical and Biomarker Science and Technologies (BST) department at Takeda is seeking a strong scientific and strategic leader to join the group as the BST Single Point of Contact (SPoC) for the Oncology Therapeutic Area to support clinical development of novel therapeutics across a range of modalities (e.g., small molecules, antibodies, bi-specifics, nucleic acids, cell therapies, and more).
• This is a strategic role that reports to the Head of BST and serves as a single point of contact to the Oncology Precision and Translational Medicine (PTM), Quantitative Clinical Pharmacology (QCP), Drug Discovery Unit (DDU), Therapeutic Area Unit (TAU), and other applicable cross-functional partners.
• The candidate will work closely with the PTM, QCP, TAU and DDU leadership to define portfolio needs in terms of bioanalytical and biomarker support, translate the needs into the BST strategy and plans, monitor execution and ensure timely fit-for-purpose assay and data delivery to support portfolio progression.

How you will contribute:

• The BST oncology SPoC will be the face of BST to functions within PTS (e.g., DMPK, DSRE, Imaging, etc.) and external partners ensuring a consistent BST strategy is messaged between BST Leads and stakeholders. Attends applicable meetings for cross-functional alignment.
• Responsible for strategy and deliverables in collaboration with BST Leads, Functional Heads and Key Stakeholders (DDU, TAU, PTS, PTM, QCP, etc.) providing guidance to BST Leads on scientific strategy and execution relating to all BST deliverables (study start-up, context-of-use-based assays and associated regulatory guidance, clinical development plans, study protocols, testing strategies, data review and QC, database locks, clinical study reports, regulatory filings and communications, etc.). They may assist in issue resolution and escalate issues as needed.
• Maintains portfolio level book of work, ensuring adequate resourcing and skill alignment, and assist in budget review.
• Reviews relevant content in key reports, governance documents that contain BST content, and regulatory documentation and communications (e.g., protocols, CSR, IND, NDA, BLA, PMA, briefing books, investigator brochures, Health Authority filings and queries, etc.). They may assist in the writing of Regulatory Responses to Health Authority Inquiries, Questions, and Requests for Information and escalate to the BST LT (Leadership Team) and/or stakeholders as needed.
• Participates in Due Diligence and other alliance opportunities for corresponding TAU/DDU, delegating to SME (Subject Matter Expert) as needed.
• Cultivates cross-program efficiencies, learnings, and aligned practices. Influences and inspires team members, and maintains a culture of innovation, scientific rigor, operational excellence, and collaboration.
• Success in this role will be evaluated by the ability to build effective partnership with relevant colleagues within PTS, PTM, QCP, DDU, TAU and other collaborators, align and deliver on BST deliverables with a focus on high-quality, fiscally responsible and timely delivery of PK, immunogenicity and biomarker data for clinical trials.
• Develops and mentors junior DMPK team members.

Minimum Requirements/Qualifications:

• PhD degree in a scientific discipline with 10+ years' experience, or MS with 14+ years' experience, or BS with 16+ years’ relevant experience in immunology, oncology and/or immuno-oncology, new modalities, a deep understanding of bioanalytical and biomarker strategies, applicable regulatory guidance, clinical trials, endpoints and deliverables.
• 10+ years in the biotechnology or pharmaceutical industry and should be able to work with the BST leads and SME to identify and resolve issues related to drug development and clinical asset progression and decision making.

Locations: Boston, MA

Worker Type: Employee

Worker Sub-Type: Regular

Time Type: Full time