Head of Oral Drug Products

Description

• Owns the global Oral Drug Product strategy and operating model to deliver phase-appropriate, scalable, and robust oral dosage forms across the pipeline and lifecycle.
• Accountable for oral drug product design and development from pre-formulation through clinical and commercial readiness, including selection of dosage form, excipients, and process pathway consistent with target product profile.
• Leads development of robust oral formulations and control strategies using QbD principles, including identification of CQAs, CPPs, design space (where appropriate), and lifecycle management plans.
• Oversees oral process development and scale-up (e.g., blending, granulation, compression, coating, encapsulation, hot-melt extrusion, spray drying, 3D/continuous manufacturing where applicable), including tech transfer to internal sites and/or CMOs through PPQ and commercialization.
• Accountable for CMC deliverables for global submissions (IND/CTA/NDA/MAA variations), ensuring high-quality module content, responses, and inspection readiness for oral drug products.
• Establishes platform approaches and standards for oral dosage forms (e.g., enabling formulations, pediatric/geriatric considerations, modified release strategies) to increase reuse and reduce cycle time.
• Drives science- and data-based selection and management of CMOs/CDMOs for oral products, including governance, performance, supply risk mitigation, and technical oversight.
• Partners effectively with Analytical, Drug Substance, Device (as needed), Regulatory CMC, Quality/GSQ, Supply Chain, and Commercial to assure robust product and process strategies through launch and beyond.
• Builds a high-performing global organization; develops talent, ensures appropriate resourcing across programs, and drives a culture of innovation, compliance, and continuous improvement.

Qualifications

• Bachelors degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science and 25+ years relevant industry experience.
• Masters degree in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 20+ years relevant industry experience.
• PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 15+ years relevant industry experience.
• Demonstrated people and program management skills, critical and out-of-the-box thinking ability.
• Demonstrated ability to anticipate issues and manage a team to proactively implement solutions.
• Experience in assuring the implementation of required quality processes and standards to facilitate smooth transition from product development to commercialization.
• Demonstrated expertise in writing regulatory documents.
• Understands the structure, functions, and methods of the global Takeda organization and overall Takeda R&D and Commercial operations.
• Excellent organizational and communication skills. Has the ability to influence at all levels of the organization and manage projects and initiatives across businesses and the globe.
• Demonstrated ability to negotiate difficult issues and arrive at mutually beneficial solutions.
• Ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with product quality and regulatory compliance.
• Demonstrated ability to effectively lead and motivate a team of direct reports, build on strengths, and address areas for improvement.
• Proven record of building mutually-respectful relationships across global regions and companies in order to foster communication and achieve strategic goals.