Senior Director, Analytical Development & Strategy Remote

Praxis Precision Medicines, Inc.; Boston (MA); Remote; USD 250,000 - 275,000; Full time

Benefits offered by this job

Stock incentives

Employee stock purchase plan (ESPP)

Discretionary quarterly bonus

Generous PTO

Job summary

Praxis Precision Medicines, Inc. is seeking a Senior Director to lead Analytical Development for small molecules and oligonucleotides, setting scientific direction and building the team.

You will guide method development, specifications, and control strategies across development stages, working with Development CMC, QA, Regulatory Affairs, and Clinical Supply. This is a hands-on leadership role in a growing organization.

Qualifications

• Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related field with 15+ years of pharma/biotech experience.
• Experience developing and validating analytical methods and establishing control strategies for drug substance and product.
• Direct small molecule analytical development experience; ASO/siRNA analytics preferred.
• Experience authoring analytical CMC content for 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 building a technical team.
• Strong knowledge of ICH guidelines, USP/EP/JP compendial requirements, and GMP regulations.
• Clear communication across scientific, operational, and executive discussions; CNS/rare disease exposure a plus.
• Ownership mindset with rigorous, urgent decision-making for patients' benefit.

Responsibilities

• Set the analytical strategy for drug substance and drug product across portfolios and determine program needs at each milestone.
• Lead analytical method development, qualification, validation, transfer, and lifecycle management with Quality and Regulatory.
• Deliver regulatory-ready analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions; represent Analytical Development with health authorities.
• Oversee CDMOs, CROs, and contract testing labs, including method transfers and investigations of OOS/OOT results.
• Build the function by hiring, coaching, and developing the analytical team and defining its structure.
• Coordinate with Process Development, Formulation Development, Clinical Supply, Quality, Regulatory, and program teams to support decisions and timelines.
• Champion data integrity, GMP compliance, and continuous improvement; stay current with regulatory expectations and new technologies.

Skills

Analytical method development

Team leadership

Regulatory CMC knowledge

Cross-functional collaboration

Strategic scientific thinking

Education

Ph.D. in Analytical Chemistry or related field

15+ years pharma/biotech experience

M.S./B.S. with commensurate experience

Job description

Praxis Precision Medicines, Inc. is seeking a Senior Director to lead Analytical Development for small molecules and oligonucleotides, setting scientific direction and building the team.

You will guide method development, specifications, and control strategies across development stages, working with Development CMC, QA, Regulatory Affairs, and Clinical Supply. This is a hands-on leadership role in a growing organization.