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 Role
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. 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 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 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., 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 trial.
- Participate in the clinical trial risk assessment.
- Review medical coding of clinical trial data, throughout the lifecycle of a clinical trial.
- Review protocol deviations to identify safety trends that could require modification of the protocol.
- Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports.
- Review and oversight of serious adverse events, including review of case narratives.
- 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.
Requirements/ Qualifications
- 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.
- Ability to work on site Monday, Tuesday & Thursday.
Experience and Knowledge
- 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.
- Strong attention to detail and excellent organization skills.
- Strong interpersonal skills and communication skills (both written and oral).
- Strong leadership skills, self-motivated and adaptable to a dynamic environment.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Willingness to travel as needed.
Salary & Benefits
The 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.
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