Manager/Senior Manager, Clinical and PV Quality at Axsome Therapeutics

New York, NYFull-timeQualityPosted 2 days ago

About the Role

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 <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">www.axsome.com</a> and follow us on <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">LinkedIn</a> and <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">X</a>.    About This Role   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.   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.  This position will report to the Senior Vice President, Quality.  <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 Axsome’s 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.   Job Responsibilities and Duties include, but are not limited to, the following:  <ul> <li> Partner with key functions (Clinical Operations, Pharmacovigilance) and interface functions (e.g. Medical Affairs and Commercial) to support a compliance journey; driving and achieving a “first time right” approach in relevant issue and initiatives. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">Support the development, implementation, and improvement of corporate quality systems that support early, mid and late phase clinical programs and post marketing activities.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Provide GCP / GVP requirements input into the development and implementation of Quality (GxP) systems. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Provides expertise and guidance on applicable regulations to specialty pharma/clinical development and pharmacovigilance teams, to proactively identify compliance issues/risks and recommend mitigation.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Identify and address GCP / GVP compliance issues across Axsome clinical and pharmacovigilance systems and processes to ensure a state of readiness for regulatory inspection.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Develop and implement a risk-based GCP and GVP audit program. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Execute GCP / GCP-GcLP / GVP internal audits (i.e. adherence to SOPs, company policies, and regulations/standards) or external audits (adherence to contractual agreements, plans and regulations / standards). <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Develop and facilitate GCP/GVP/GXP training for functional areas and personnel involved in the execution of clinical trials and post marketing activities. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Identify, monitor and report compliance trends and risks for trials and post market activities.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Lead and support investigations into significant departures from GVP / GCP, including serious breaches / scientific misconduct.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Escalate compliance issues identified to senior management.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Review and provide input to clinical documentation (e.g. protocols, study reports, IB etc.)<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1">Contribute to the development of Clinical Operations, Safety and Clinical Quality and Compliance, and Pharmacovigilance systems and standards.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1">Develop and measure GCP and GVP quality metrics to drive consistent quality standards throughout the organization. Maintain relevant knowledge of appropriate GxP requirements and developments as they impact company SOPs and compliance with GxP and communicate these to the QA team and QA management, as applicable.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> <li data-leveltext="" data-font="Symbol" data-listid="10" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="15" data-aria-level="1">Provide information relating to Quality to stakeholders, as required (e.g. PV System Master File).<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> Requirements / Qualifications  <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1">Bachelor’s degree in a scientific discipline or field<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1">5+ years of experience within the pharmaceutical and R&D industry, of which a minimum of 3 years hands-on GCP and/or GVP QA experience.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> Experience, Knowledge and Skills<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":4278190080,"335572075":0,"335572076":0,"335572077":4278190080,"335572079":0,"335572080":0,"335572081":4278190080,"335572083":0,"335572084":0,"335572085":4278190080,"335572087":0,"335572088":0,"335572089":4278190080,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}">  <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1">Experience in a compliance role.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1">Extensive knowledge and practical application of ICH, GCP / GVP and applicable guidance documents.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1">Ability to identify proactively and anticipate risk of non-compliance in a complex environment.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1">Experience of hosting or managing GCP and/or GVP inspections is desirable.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1">Experience in clinical operations and handling trial essential documents is preferred. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1">Proficient MS Office skills.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1">Excellent planning and organizational skills.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1">Exceptional attention to detail.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="11" data-aria-level="1">Strong interpersonal skills and a team player.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="12" data-aria-level="1">Ability to influence senior leaders within the organization on matters of quality importance. <span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="13" data-aria-level="1">Effective communication skills, both verbally and written.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul> <ul> <li data-leveltext="·" data-font="Noto Sans Symbols" data-listid="1" data-list-defn-props="{"335552541":1,"335559685":720,"335559991":360,"469769226":"Noto Sans Symbols","469769242":[8226],"469777803":"left","469777804":"·","469777815":"hybridMultilevel"}" data-aria-posinset="14" data-aria-level="1">Proven ability to manage complex projects.<span data-ccp-props="{"201341983":0,"335551550":6,"335551620":6,"335559739":160,"335559740":259,"335572071":0,"335572072":0,"335572073":0,"335572075":0,"335572076":0,"335572077":0,"335572079":0,"335572080":0,"335572081":0,"335572083":0,"335572084":0,"335572085":0,"335572087":0,"335572088":0,"335572089":0,"469789798":"nil","469789802":"nil","469789806":"nil","469789810":"nil","469789814":"nil"}"> </li> </ul>   Salary & Benefits   The anticipated salary range for this role is $120,000 - $140,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.  Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<span data-ccp-charstyle="eop" data-ccp-charstyle-defn="{"ObjectId":"920dbcde-2834-5e15-a5fa-062170b236ba|1","ClassId":1073872969,"Properties":[469777841,"Century Gothic",469777842,"Century Gothic",469777843,"Century Gothic",469777844,"Century Gothic",469769226,"Century Gothic",268442635,"24",469775450,"eop",201340122,"1",134233614,"true",469778129,"eop",335572020,"1",469778324,"Default Paragraph Font"]}">    Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

About the Role

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