Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role: Axsome Therapeutics is seeking an Associate Director, HEOR Analytics. This is a hands-on, technical role responsible for designing and executing real-world evidence (RWE) analyses using large-scale healthcare datasets, including administrative claims, electronic health records (EHR/EMR), and other real-world data sources. This role combines advanced statistical programming, study design, and analytical expertise to generate rigorous evidence supporting evidence generation priorities. The individual will lead the development of study protocols, statistical analysis plans, and study reports in partnership with the HEOR Lead & Medical Strategy colleagues, oversee programming and execution of analyses inclusive of quality control procedures, and deliver high-quality evidence to inform value demonstration, payer engagement, and scientific publications. This role is based at Axsome’s HQ in New York City with an on-site requireme
Associate Director, Analytical Development and Quality Control
Role overview
Job description
At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions. We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team. What You’ll Do: The Associate Director, Analytical Development and Quality Control will support analytical development and QC operations for clinical development and commercialization of Kailera’s pipeline compounds. The individual will provide technical expertise and will work closely with cro
…What they are looking for
Skills & requirements
Qualification
A bachelor’s degree and 10+ years of experience in the pharmaceutical/biotech industry with experience in late phase drug substance development, NDA submissions, PAI readiness, and commercial launch in accordance with global CMC regulatory filings (IND/NDA/MAA, etc.). Or an advanced degree with 5+ years Knowledge of peptide chemistry and strong understanding of peptide degradation pathways and impurity control strategy. Experience in the analytical support of drug substance PPQ/Process Validation. Demonstrated analytical project leadership and cross-functional team participation. Experience in setting commercial specifications. Experience in authoring regulatory documents, including NDA experience Knowledge and strong understanding of drug development activities with respect to cGMP, quality systems, global regulatory requirements, and USP, EP, JP, and CHP requirements. Strong understanding of all applicable ICH guidelines. Method validation experience. Experience with oversight of the analytical activities at CDMOs and/or CTLs. Sound problem-solving skills with technically driven decision-making ability. Effective written and verbal communication and interpersonal skills. Innovati
Department · Analytical Dev & QC
Hiring company
Kailera Therapeutics, Inc.
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