R1 Therapeutics is a California-based (with presence in North Carolina and Boston) clinical-stage biotechnology company dedicated to transforming outcomes for patients living with chronic kidney disease. R1 is building a portfolio of differentiated therapies to address the interconnected complications of CKD—starting with hyperphosphatemia, where unmet need remains high and the standard of care has gone largely unchanged for decades.

The company’s lead asset, AP306 a small molecule, is a first-in-class pan phosphate transporter inhibitor with Phase 2a proof-of-concept and the potential to deliver meaningfully better efficacy with a lower pill burden. R1 launched in 2026 with a $77.5M Series A backed by Abingworth, F-Prime Capital, DaVita Venture Group, and U.S. Renal Care, and is advancing AP306 into Phase 2b with topline data expected in 2027.

Position Description

The Director, Drug Product will lead all drug product development and manufacturing activities at R1 Therapeutics, serving as the technical and operational owner for formulation development, drug product manufacturing, and clinical supply across the company’s pipeline. This role is responsible for developing and executing the drug product strategy—from formulation development and process development through scale-up, tech transfer, and clinical supply—while ensuring regulatory compliance and supply readiness. The Director will manage external CDMO partnerships and collaborate closely with the Head of CMC, drug substance, analytical development, and regulatory affairs colleagues to advance AP306 into Phase 2b and support future pipeline growth. This position reports to the Head of CMC.

Key Responsibilities

• Own and execute the drug product development strategy for AP306 and future pipeline assets, including formulation development, process development, and dosage form optimization
• Lead technology transfer activities to CDMOs for drug product manufacturing; serve as the primary technical point of contact for external drug product manufacturing and packaging partners
• Oversee process development, scale-up, and process validation planning in alignment with regulatory expectations and clinical program timelines
• Author and review drug product CMC sections for regulatory submissions, including INDs, CTAs, and IND amendments; support NDA/BLA preparation as programs advance
• Ensure GMP compliance across all drug product manufacturing operations; lead or support regulatory agency inspections and responses related to drug product
• Manage drug product clinical supply chain, including batch scheduling, labeling, packaging, and distribution logistics in coordination with clinical operations
• Design and oversee drug product stability programs; ensure appropriate shelf life and storage conditions are established and maintained
• Collaborate with analytical development on drug product release testing strategies, specification setting, and method validation
• Track and communicate drug product program status, risks, and mitigation strategies to the Head of CMC and broader leadership team
• Evaluate CDMO partners for drug product manufacturing and packaging; contribute to contract negotiations and governance of external relationships

Education and Experience Requirements

• 10+ years of experience in drug product development and manufacturing within the pharmaceutical or biotechnology industry
• Advanced degree (PhD or MS) in pharmaceutical sciences, chemical engineering, chemistry, or a related discipline required
• Demonstrated expertise in solid oral dosage form development (tablets, capsules) for small molecules, including formulation development, process development, and scale-up
• Experience managing CDMOs and executing drug product technology transfers; strong understanding of CDMO oversight, quality systems, and batch record review
• Solid regulatory knowledge, including authorship of drug product CMC sections for IND and/or NDA filings; familiarity with ICH Q8, Q9, Q10 guidelines
• Working knowledge of GMP manufacturing requirements and experience supporting regulatory inspections related to drug product operations
• Experience with drug product stability programs, shelf-life assessment, and ICH stability guidelines
• Ability to work effectively in a lean environment; hands-on, resourceful, and comfortable building processes without well-established infrastructure
• Strong written and verbal communication skills; ability to translate complex technical topics for cross-functional and non-technical audiences

Why Join R1

• Opportunity to shape the strategy of a company redefining treatment for kidney disease
• Highly visible role with direct impact on company direction and growth
• Collaborative, mission-driven culture with a focus on innovation and urgency
• Ability to work at the forefront of science while driving meaningful business outcomes