Remote Senior Director — Small Molecule API Development

Otsuka America Pharmaceutical Inc.; Carson City (NV); Remote; USD 231,000 - 345,000; Full time

Benefits offered by this job

Comprehensive medical, dental, vision

401(k) match

Tuition reimbursement

Paid holidays and leave

Job summary

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategy, execution, and optimization of APIs from candidate nomination to commercial readiness.

You will manage a global team of scientists in a fully virtual model and partner with CDMOs to deliver scalable, compliant manufacturing. Responsibilities include defining development strategies, driving process chemistry improvements, regulatory submissions, and portfolio planning.

Qualifications

• PhD in Organic Chemistry, Process Chemistry, Chemical Engineering, Pharmaceutical Sciences or related field preferred.
• 15+ years in pharmaceutical/biotech drug substance development.
• Minimum 5 years leading scientific teams and managing people.
• Proven success advancing multiple small molecule programs from nomination through late-stage development.

Responsibilities

• Develop and execute phase-appropriate drug substance development strategies from candidate nomination through commercial readiness.
• Lead cross-functional teams including CDMOs to ensure scalable, compliant manufacturing processes.
• Provide regulatory strategy input and support for filings (INDs, CTAs, NDAs).
• Mentor and develop a high-performing team of scientists and engineers.
• Oversee budgets and external development expenditures.

Skills

Strategic leadership

Process chemistry

CDMO management

Regulatory submissions

Team development

Cross-functional collaboration

Education

PhD in Organic Chemistry or related field

Master's degree considered

Job description

Otsuka America Pharmaceutical, Inc. seeks a Senior Director of Small Molecule Drug Substance Development to lead strategy, execution, and optimization of APIs from candidate nomination to commercial readiness.

You will manage a global team of scientists in a fully virtual model and partner with CDMOs to deliver scalable, compliant manufacturing. Responsibilities include defining development strategies, driving process chemistry improvements, regulatory submissions, and portfolio planning.