Senior Medical Director, Clinical Research

4 weeks ago

New York NY, United States Axsome Therapeutics Full time

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. Axsome 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. 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.
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 projects
Provide therapeutic area training
Act 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 brochures
Provide safety training for clinical sites and internal team members
Engage with clinical team to answer eligibility and other medical related questions associated with clinical trials (e.g., Author or support the authorship of all required medical plans (e.g., Safety Monitoring Plan, Medical Monitoring Plan) for each clinical trial
Participate in the clinical trial risk assessment
Review medical coding of clinical trial data, throughout the lifecycle of a clinical trial
Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports
Provide medical interpretation of clinical safety data and determine the medical significance of any findings
Contribute to oversight of external safety vendor and provide medical input as needed
Contribute to the generation of aggregate safety reports including annual IND safety reports and periodic benefit risk evaluation reports
Review, analyze, and assess clinical trial safety data, and present the results as needed
Consult with external safety vendor and internal PV Operations as needed
Collaborate with relevant members of the study team, and vendor clinical staff who provide medical monitoring support for ongoing clinical trials
Lead medical input for scientific publications (e.g., abstracts, posters, papers) for scientific meetings and journals
Collaborate with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community
Contribute to regulatory submissions including authoring relevant sections of the submissions
Contribute to the development of internal processes including SOPs, guidelines, and Work Instructions
MD 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/neurology
Postgraduate training with at least 5 years of drug safety, clinical development, or medical affairs experience in the pharmaceutical industry
Understanding 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 SOPs
Significant experience with preparation of responses to Regulatory Authorities, IND/NDA submissions
Proven ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies leading to obtaining results
Willingness to travel as needed

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