Senior Director, Head of Analytical Development

Job not on LinkedIn

🔥 2 minutes ago

🇺🇸 United States – Remote

💵 $250k - $275k / year

⏰ Full Time

🟠 Senior

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Praxis

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 2002

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Praxis is a company dedicated to connecting patients with meaningful clinical trial opportunities. With a focus on creating customized recruitment programs, Praxis utilizes a variety of specialized tools and extensive experience across various therapeutic areas to ensure they reach the right patients worldwide. Established in 2002, the company emphasizes the importance of patient engagement and utilizes sophisticated data insights to enhance the patient journey in clinical research.

📋 Description

• Set and execute analytical strategy for drug substance and drug product across small molecule and oligonucleotide portfolios • Lead analytical method development, qualification, validation, transfer, and lifecycle management • Establish specifications, comparability approaches, and control strategies with Process Development, Quality, and Regulatory Affairs • Author and review analytical CMC content for IND, IMPD/CTA, and NDA/MAA submissions • Represent Analytical Development in health authority interactions • Oversee CDMOs, CROs, and contract testing laboratories, including method transfers, stability programs, and OOS/OOT investigations • Hire, coach, and develop the analytical team • Partner with Development CMC, Process Development, Formulation Development, Clinical Supply, Quality, Regulatory Affairs, and program teams • Lead CMC teams and represent the CMC function on cross-functional program teams • Champion data integrity, GMP compliance, continuous improvement, analytical technologies, and regulatory expectations

🎯 Requirements

• 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, operational, and executive discussions • Experience in CNS or rare disease development is a plus • Ownership mindset; scientific rigor and urgency in decision-making

🏖️ Benefits

• 99% of the premium paid for medical, dental and vision plans • Company-paid life insurance • AD&D benefits • Disability benefits • Voluntary plans to personalize coverage • Dollar-for-dollar 401(k) match up to 6% on eligible contributions • Long-term stock incentives • ESPP • Discretionary quarterly bonus • Extremely flexible wellness benefit • Generous PTO • Paid holidays • Company-wide shutdowns