Senior Director, Small 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 escalate 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 commercial readiness.

• Lead, mentor, and develop a high-performing team of process chemists, scientists, and drug substance development professionals.
• Build technical capabilities within the drug substance development team to support progression of programs from candidate nomination through commercial readiness.
• Foster a culture of scientific rigor, innovation, accountability, collaboration, and continuous improvement.

Qualifications

Education

• PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline preferred.
• Master's degree with significant relevant industry experience may be considered.

Experience

• 15+ years of progressive experience in pharmaceutical or biotechnology drug substance development.
• Demonstrated leadership experience in small molecule process chemistry and API development.
• Minimum of 5 years of experience leading scientific teams and managing people.
• Proven success advancing multiple small molecule programs from candidate nomination through late-stage clinical development and commercial readiness.
• Significant experience leading process chemistry, technology transfer, scale-up, and API commercialization activities.
• Extensive experience managing CDMOs and external development partners.
• Demonstrated ability to lead cross-functional programs within a matrixed organization.
• Experience managing departmental budgets and resource planning.

Technical Expertise

• Deep expertise in synthetic organic chemistry and pharmaceutical process development.
• Strong understanding of route selection, process optimization, scale-up, technology transfer, process characterization, process validation, and commercial manufacturing.
• Comprehensive knowledge of global drug substance CMC requirements and applicable regulatory guidelines.
• Experience with impurity control strategies, genotoxic impurity management, and process control strategies.
• Strong understanding of pharmaceutical development principles from early development through commercialization.
• Familiarity with contemporary manufacturing technologies and external manufacturing business models.

Leadership Competencies

• Strategic thinker with strong scientific judgment and business acumen.
• Demonstrated ability to build, inspire, and lead high-performing technical organizations.
• Strong project management and prioritization capabilities.
• Proven ability to influence stakeholders and drive decision-making across complex organizations.
• Excellent verbal, written, and presentation skills.
• Strong interpersonal skills with the ability to develop productive relationships internally and externally.
• Ability to operate effectively in a fast-paced and evolving development environment.

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $230,720.00 - Maximum $345,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits:  Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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Disclaimer: 

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting [email protected]. 

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