Vice President CMC (Small Molecules and Oligonucleotides)

Role Summary

Vice President CMC (Small Molecules and Oligonucleotides) overseeing the entire Takeda portfolio for pharmaceuticals, including synthetic small molecules, synthetic peptides, and synthetic oligonucleotides. The role collaborates with Executives (VP/SVP) in R&D (Discovery and Therapeutic Area Units - TAUs), GRA, GMS, Global Quality, and Commercial. Location: Boston, MA.

Responsibilities

• Develop innovative strategies for the management of development products
• Develop processes, systems and infrastructure to assure regulatory conformance prospectively while managing conformance retrospectively for post-approval products
• Manage the pipeline of combination products, bringing current products up to today’s standards
• Represent CMC and GRA on key governance committees and drive adoption and registration of new technologies/molecules in the pipeline (small molecules, synthetic peptides, oligonucleotides) with novel delivery approaches
• Lead senior individuals, enabling hiring, mentoring, and development of capable teams that can represent the organization on critical topics
• Wear multiple hats: navigate ambiguity and lead effectively in uncertain environments
• Serve as single point of contact with key Takeda leaders (GRA, R&D, GMS, GQ) interfacing with Research, GMS, GQ, and GRA LT / Commercial / GPT
• Research – enable fast prosecution of the portfolio and support adoption of novel in-silico approaches
• GMS – act as the GRA representative on Small Molecules and Oncology Operations Leadership team to maintain licenses globally through proactive changes and addressing legacy portfolio conformance
• GQ – serve as the GRA representative on the Small Molecule Quality Council and enable proactive quality/compliance approaches
• GRA LT / Commercial / GPT – engage with therapeutic area heads, GPTs/commercial teams and pharm sciences to advance innovation using risk-based principles
• Lead with the ability to manage ambiguity, guide teams under high-stress conditions, and drive change without compromising ongoing work and timelines
• Communicate concisely and clearly across all levels of the organization, including stakeholders in R&D, GMS, GQ, and Commercial

Qualifications

• Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline
• Languages: Fluent in English (oral and written); additional languages desirable
• Minimum of 20 years of experience within regulatory agencies or the pharmaceutical industry, including significant leadership experience in Regulatory Sciences
• Strong understanding of international regulations and policies (e.g., US FDA, EU, PMDA, NMPA, WHO)
• Active engagement with major industry associations (e.g., EFPIA, PhRMA, AAPS, PDA, ISPE, DIA) and regulator/industry initiatives (e.g., ICH)
• Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills; proven track record of cross-border collaboration to drive patient benefit
• Ability to relate to internal stakeholders and interface with external regulatory authorities to enable science- and risk-based decisions
• High organizational awareness and extensive experience working cross-functionally
• Desired technical skills: experience in technical development, manufacturing, and/or testing of pharmaceuticals

Education

• Advanced Degree or PhD in Life Sciences, Pharmacy or Medicines, or related discipline