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Manager/Senior Manager, Clinical and PV Quality

axsometherapeutics · New York, NY · New York, New York, United States
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<p><span data-contrast="none">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 </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DQQIa-gYpjh8WDA8s-h_cxtiLRzsSWm9ZOooeS2xh8kY8-FumfaVAL8G_hC6J6y6LuXKTBTKoXqd1vp9_5M907w%3D%3D&data=05%7C02%7Chtonn%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174772553640%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=ZnnFAe%2F%2B1O6C6uuloOws3WO%2Frgs6a2yw9Vs%2FtYiVGpI%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">www.axsome.com</span></span></strong></a><span data-contrast="none"> and follow us on </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3D_1y-uBUKIw3KWJ6Y-geQ15plDCyHIG7Py7UrynaLe_a3Ox38W8ZNivhkg6dSO_EWMIT6bNTFwzm046vzW_oTZatsU1_U7o9NHovDE-a03JE%3D&data=05%7C02%7Chtonn%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174772571585%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=P%2BviUh%2FBirzNjnwI2MDCMDz3KRkwWyzOl68CG%2FvnIUI%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">LinkedIn</span></span></strong></a><span data-contrast="none"> and </span><a href="https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.globenewswire.com%2FTracker%3Fdata%3DF1-pkxXL1lZ12X8uiqEChktKQU5vuDQzzM1QTwq95wNWfa9_p27EwyIBpUngNstn&data=05%7C02%7Chtonn%40axsome.com%7Cce46a392b4314bf2fc5408deb4f815db%7Cb3096ec47bba4e2f9c92818dea8094e1%7C0%7C0%7C639147174772582267%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=L4EpDG1NpSnHvar3GrQC30QtO3BpInoqYdH1JVQudCI%3D&reserved=0"><strong><span data-contrast="none"><span data-ccp-charstyle="Hyperlink">X</span></span></strong></a><span data-contrast="none">.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p> <br><strong><span data-contrast="none">About This Role </span></strong><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="none">Axsome Therapeutics is seeking a Manager/Senior Manager Clinical and PV Quality who will provide Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) oversight of Axsome’s clinical trial activities and related records and processes to assure quality and management in accordance with key global regulations (FDA, Health Canada, EMA and MHRA), ICH guidance (GCP E6, E2 and other relevant guidelines), company processes (such as SOPs) and all other applicable regulations. </span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="none">The Manager/Senior Manager Clinical and PV Quality will manage cross functional relationships with internal and external stakeholders and be the lead Quality GCP and GVP representative on clinical teams for ongoing Axsome-sponsored trials and post-market activities.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><span data-contrast="none">This position will report to the Senior Vice President, Quality.</span><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><em><span data-contrast="none"><span data-ccp-charstyle="normaltextrun" data-ccp-charstyle-defn="{"ObjectId":"ac0262f4-8a9e-5820-b908-2d943c5f7113|1","ClassId":1073872969,"Properties":[469777841,"Century Gothic",469777842,"Century Gothic",469777843,"Century Gothic",469777844,"Century Gothic",469769226,"Century Gothic",268442635,"24",469775450,"normaltextrun",201340122,"1",134233614,"true",469778129,"normaltextrun",335572020,"1",469778324,"Default Paragraph Font"]}">This role is based at </span><span data-ccp-charstyle="normaltextrun">Axsome’s</span><span data-ccp-charstyle="normaltextrun"> HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. </span></span></em><span data-ccp-props="{"335551550":6,"335551620":6}"> </span></p> <p><strong><span data-contrast="none">Job Responsibilities and Duties</span></strong><span data-contrast="none"> 

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