Senior Director, Head of Analytical Development

This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

We are looking for a Senior Director to lead Analytical Development across our small molecule and oligonucleotide portfolios. You will set the scientific direction, build the team, and ensure our methods, specifications, stability programs, and control strategies are ready for each stage of development, from pre-IND work through potential NDA/MAA approval. This is a hands-on leadership role in a growing, agile organization.

You will make consequential technical decisions, work closely with colleagues across Development CMC, Quality, Regulatory Affairs, and Clinical Supply, and hold external partners to a high standard. Your work will help move promising molecules toward medicines for patients.

• Set the analytical strategy. Define and execute an approach for drug substance and drug product across the small molecule and oligonucleotide portfolios. Make clear choices about what each program needs now and what it will need at the next clinical or regulatory milestone.
• Build reliable methods and controls. Lead analytical method development, qualification, validation, transfer, and lifecycle management. Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs.
• Deliver regulatory-ready science. Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions. Represent Analytical Development in health authority interactions and explain the science clearly under scrutiny.
• Lead external execution. Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and investigations of out-of-specification or out-of-trend results. Surface risks early and drive them to resolution.
• Build the function. Hire, coach, and develop a strong analytical team. Shape its structure and capabilities as the portfolio grows, while giving people clear ownership and direct, useful feedback.
• Connect the work to program decisions. Partner with Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams so analytical deliverables support sound decisions and meet program timelines. Lead CMC teams and represent CMC function on cross-functional program teams.
• Raise the standard. Champion data integrity, GMP compliance, and continuous improvement. Stay current with analytical technologies and regulatory expectations, and apply new approaches when they will improve the work.

• A Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field and 15+ years of relevant pharmaceutical or biotech experience; or an M.S./B.S. with commensurately greater experience.
• Deep experience developing and validating analytical methods and establishing control strategies for drug substance and drug product, from early development through late-stage or commercial readiness.
• Direct small molecule analytical development experience. Experience with ASO, siRNA, or other nucleic acid therapeutic analytics is strongly preferred.
• A record of authoring and defending analytical CMC content in regulatory filings and participating in health authority interactions.
• Experience directing CDMO/CRO relationships and outsourced analytical testing, with the judgment to identify issues and resolve them.
• People leadership experience and the ability to build a technical team in a growing organization.
• Strong working knowledge of ICH guidelines, USP/EP/JP compendial requirements, and current GMP regulations.
• Clear communication and sound judgment across scientific,…