Remote Senior Director, Analytical Development & Strategy

Praxis Precision Medicines; United States; Remote; USD 250,000 - 275,000; Full time

Benefits offered by this job

Discretionary quarterly bonus

Stock incentives

ESPP

Generous PTO

Company-wide holidays

Job summary

Praxis Precision Medicines is seeking a Senior Director to lead Analytical Development across small molecule and oligonucleotide portfolios. You will define scientific direction, build the team, and ensure methods, specifications, and control strategies are ready from pre-IND to potential NDA/MAA approval.

This is a hands-on leadership role involving cross-functional collaboration and external partner management to advance programs toward patients.

Qualifications

• PhD in Analytical Chemistry or related field with 15+ years in pharma/biotech.
• Deep experience in analytical method development and validation for drug substance and drug product.
• Experience directing CDMO/CRO relationships and outsourced analytics.

Responsibilities

• Set analytical strategy for drug substance and drug product across portfolios.
• Lead method development, qualification, validation, transfer and lifecycle management.
• Prepare regulatory-ready CMC content for IND/IMPD/CTA and NDA/MAA submissions.
• Oversee external labs, surface risks early and drive resolution.
• Hire and develop a high-performing analytics team.
• Collaborate with Process Development, Quality, Regulatory Affairs and Clinical Supply.

Skills

Analytical Chemistry

Team Leadership

Regulatory filings

CDMO management

GMP compliance

Cross-functional leadership

Education

PhD in Analytical Chemistry

MS/BS with extensive experience

Tools

HPLC/LC-MS

Job description

Praxis Precision Medicines is seeking a Senior Director to lead Analytical Development across small molecule and oligonucleotide portfolios. You will define scientific direction, build the team, and ensure methods, specifications, and control strategies are ready from pre-IND to potential NDA/MAA approval.

This is a hands-on leadership role involving cross-functional collaboration and external partner management to advance programs toward patients.