How youβll make an impact:
The Senior Director of Early Phase Formulation Development will provide scientific leadership for preformulation and early stage formulation activities across the small molecule portfolio, driving enabling formulation strategies from candidate selection through early clinical development to address drug delivery and bioavailability challenges. Partners with Research, DMPK, and CMC to advance programs through IND and into early-stage clinical studies.
Responsibilities:
- Lead early formulation development (preformulation characterization, enabling formulation strategies, drug product design) for preclinical and early clinical stages
- Apply expertise in preformulation, biopharmaceutics, and enabling formulation to support candidate progression from discovery through IND
- Drive innovation in enabling formulation technologies to address solubility and bioavailability challenges
- Design and execute phase-appropriate formulation and drug product strategies for preclinical toxicology and early clinical programs
- Coordinate with external CROs and CDMOs; provide scientific/technical guidance
- Establish phase-appropriate best practices, SOPs, and experimental frameworks
- Manage outsourced activities to meet scientific quality, timelines, and objectives
- Support CMC regulatory strategy for drug product development; contribute to drug product IND sections
- Ensure compliance with applicable GMP and regulatory requirements
Skills and experience youβll bring:
- Ph.D. in Pharmaceutics/Pharmaceutical Sciences/Chemical Engineering (or related); 15+ years relevant industry experience focused on early-stage formulation development
- Track record advancing small molecule programs from discovery through IND and into clinical development
- Strong knowledge of preformulation, biopharmaceutics, formulation development, and oral solid dose manufacturing
- Deep expertise in enabling technologies for poorly soluble compounds
- Strong GMP and regulatory knowledge; experience coordinating with CROs/CDMOs
- Strong scientific communication and cross-functional collaboration
Compensation/Benefits:
- Anticipated base salary: $235,000β$330,000; eligibility for annual bonus, equity participation, and comprehensive benefits.