Location: New York, NY
Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders.
The Axsome team is comprised of a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders.
Axsome is based in New York City, New York.
The individual will serve as the medical monitor for clinical trials of Axsome products throughout their lifecycle. The individual 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. A successful candidate will be familiar with the ICH/GCP, regulatory authority’s regulations/guidelines, and applicable SOPs. This position will manage essential duties and responsibilities as independently as possible, with guidance and oversight provided by the program director when needed.
- Review clinical protocols, study reports, clinical trial supporting materials, and other related documents.
- Engage with clinical team to answer eligibility and other medical related questions associated with clinical trials.
- Provide therapeutic area training.
- Author Medical Monitoring Plan for each clinical trial.
- Safety review and oversight.
- Contribute to regulatory submissions including authoring relevant sections of the submissions.
- Author, review, and provide input for drug-safety related regulatory reports and clinical study documents.
- Contribute to the development of internal processes including SOPs, guidelines, and Work Instructions.
- Act as medical and scientific subject matter expert for expansion of the team’s pharmacovigilance capabilities.
- MD or foreign equivalent.
- Postgraduate training with at least 2 years of drug safety, clinical development or medical affairs experience in the pharmaceutical industry.
- Excellent understanding of pharmacovigilance regulatory environment with working knowledge of international regulations, initiatives, standards, Good Pharmacovigilance Practices (GVP), and Good Clinical Practice (GCP).
- Knowledge of MedDRA and WHODrug coding and terminology.
- Ability to work on complex or multiple projects and exercise independent judgment within generally defined practices and policies lead 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, adaptable to a dynamic environment.
- Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities.
- Preference to energetic candidates with a desire to think “outside the box.”
- Willingness to travel as needed.