Senior Director, Molecule Drug Substance Development

Position Summary

The Senior Director, Small Molecule Drug Substance Development provides strategic, scientific, and operational leadership for the development, optimization, scale-up, and manufacture of small molecule active pharmaceutical ingredients (APIs) from candidate nomination through commercial readiness. The position is accountable for establishing and executing comprehensive drug substance development strategies for Otsuka's small molecule assets that enable robust, scalable, compliant, and cost-effective manufacturing processes throughout the product lifecycle.

The Senior Director leads a team of scientists and process chemists responsible for the execution of drug substance development activities through all phases of development while ensuring technical excellence, operational efficiency, and regulatory compliance in a fully virtual model. The individual works closely with the global external manufacturing group to select and manage contract development manufacturing organizations (CDMOs) and leads drug substance development activities for assigned portfolio programs and contributes to portfolio planning.

Key Responsibilities

Drug Substance Development Strategy

• Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.

• Develop and execute API development plans aligned with program, portfolio, and corporate objectives.

• Provide scientific and technical leadership in route selection, process chemistry, process optimization, impurity control, scale-up, and manufacturing strategy.

• Drive development of safe, robust, scalable, and commercially sustainable manufacturing processes.

• Establish development strategies that support clinical supply, regulatory submissions, process validation, and commercial launch readiness.

• Identify and elevate technical and operational risks and implement mitigation strategies to support program timelines and organizational objectives.

• Provide scientific oversight for process characterization activities and development of process control strategies.

• Lead technical evaluations of novel technologies and manufacturing approaches that improve process robustness, productivity, safety, and cost efficiency.

• Provide strategic oversight and technical guidance for technology transfer, scale-up, and manufacturing activities performed by CDMOs.

• Contribute scientific and technical expertise to due diligence, business development assessments, and portfolio evaluations.

• Contribute to departmental planning, performance metrics, and resource strategies.

• Manage departmental budgets, external development expenditures, and consulting resources.

CMC and Regulatory Support

• Author, review, and approve drug substance sections of regulatory submissions including INDs, IMPDs, CTAs, NDAs, MAAs, and related global filings.

• Provide strategic input into drug substance regulatory strategies and health authority interactions.

• Present and defend drug substance development approaches during regulatory inspections, audits, and agency meetings as required.

• Ensure drug substance development documentation is scientifically rigorous and development activities are aligned with current regulatory expectations and industry best practices for small molecule drug substance development.

Cross-Functional and Team Development Leadership

• Partner closely with drug product development, analytical sciences, quality assurance, regulatory affairs, supply chain, and other cross-functional stakeholders to ensure alignment of drug substance development activities with overall program objectives, regulatory requirements, clinical and commercial supply needs, product development strategies, and successful advancement from candidate nomination through…