Senior Medical Director, Clinical Development - New York, United States - Axsome Therapeutics, Inc.

Description

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders.

The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.

Axsome is based in New York City.
About This RoleAxsome Therapeutics is seeking a Senior Medical Director, Clinical Development. The Medical Director will independently provide oversight of Medical Monitoring for clinical trials of Axsome products throughout their lifecycle. This role will be responsible for leading development plans and protocols for Axsome products.

Additionally, the Medical Director will assess and interpret safety data from multiple sources, including clinical trials, both at the patient level and in aggregate.

The person in this role is expected to provide input into clinical protocols, development of related study plans, supervision of study conduct, medical monitoring for trial participant safety, and contributions to annual reporting (e.g. DSURs, PSURs, PADERs, clinical safety assessments).

This position will also, when appropriate, as a result of their medical experience, contribute to clinical development and medical affairs activities as part of the broader team.

This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the senior members of Clinical Development when needed.

This role is based at our HQ in New York City and will be required to be onsite at least three days per week.

Job Responsibilities and Duties include, but are not limited to, the following:

Independently generate and review clinical trial protocols/concept sheets and investigator brochures (IBs) and collaborate directly with Key Opinion Leaders for expert feedback for assigned assets and projectsProvide therapeutic area trainingAct as a resource for the generation of informed consent forms, and review these forms for completeness in risk assessment as compared to clinical trial protocols and investigator brochuresProvide safety training for clinical sites and internal team membersEngage with clinical team to answer eligibility and other medical related questions associated with clinical trials (e.g., abnormal laboratory test result review)Author or support the authorship of all required medical plans (e.g., Safety Monitoring Plan, Medical Monitoring Plan) for each clinical trialParticipate in the clinical trial risk assessmentReview medical coding of clinical trial data, throughout the lifecycle of a clinical trialReview protocol deviations to identify safety trends that could requirement modification of the protocolProvide medical expertise in the assessment of ICSRs and aggregate drug safety reportsReview and oversight of serious adverse events, including review of case narrativesProvide medical interpretation of clinical safety data and determine the medical significance of any findingsContribute to oversight of external safety vendor and provide medical input as neededContribute to the generation of aggregate safety reports including annual IND safety reports and periodic benefit risk evaluation reportsReview, analyze, and assess clinical trial safety data, and present the results as neededConsult with external safety vendor and internal PV Operations as neededCollaborate with relevant members of the study team, and vendor clinical staff who provide medical monitoring support for ongoing clinical trialsLead medical input for scientific publications (e.g., abstracts, posters, papers) for scientific meetings and journalsCollaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber communityContribute to regulatory submissions including authoring relevant sections of the submissionsContribute to the development of internal processes including SOPs, guidelines, and Work InstructionsRequirements/ QualificationsMD or foreign equivalent specializing in neurology or with significant development experience in CNS; PharmD will be considered commensurate with extensive drug development experience with CNS/neurologyPostgraduate training with at least 5 years of drug safety, clinical development, or medical affairs experience in the pharmaceutical industryUnderstanding of pharmacovigilance regulatory environment with working knowledge of international regulations, initiatives, standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP), Council for International Organizations of Medical Sciences (CIOMS), ICH guidelines, regulatory authority regulations/guidelines, and applicable SOPsAbility to work on site Monday, Tuesday & ThursdayExperience and KnowledgeSignificant experience with preparation of responses to Regulatory Authorities, IND/NDA submissionsProven ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies leading to obtaining resultsStrong attention to detail and excellent organization skillsStrong interpersonal skills and communication skills (both written and oral)Strong leadership skills, self-motivated and adaptable to a dynamic environmentComfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing prioritiesWillingness to travel as neededSalary & BenefitsThe anticipated salary range for this role is $260,000 - $280,000.

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.#J-18808-Ljbffr