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Full-Time

Senior Medical Director

Clinical Development

Posted on 6/27/2024

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops therapies for central nervous system conditions

Biotechnology

Compensation Overview

$260k - $280kAnnually

+ Bonus + Equity

Senior

New York, NY, USA

Category
Physicians & Surgeons
Medical, Clinical & Veterinary
Requirements
  • MD or foreign equivalent specializing in neurology or with significant development experience in CNS
  • 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
Responsibilities
  • Independently generate and review clinical trial protocols/concept sheets and investigator brochures (IBs)
  • Provide therapeutic area training
  • Act as a resource for the generation of informed consent forms
  • Provide safety training for clinical sites and internal team members
  • Engage with clinical team to answer eligibility and other medical related questions
  • Author or support the authorship of all required medical plans
  • Participate in the clinical trial risk assessment
  • Review medical coding of clinical trial data
  • Review protocol deviations to identify safety trends
  • Provide medical expertise in the assessment of ICSRs and aggregate drug safety reports
  • Review and oversight of serious adverse events
  • Provide medical interpretation of clinical safety data
  • Contribute to oversight of external safety vendor
  • Contribute to the generation of aggregate safety reports
  • Review, analyze, and assess clinical trial safety data
  • Consult with external safety vendor and internal PV Operations
  • Collaborate with relevant members of the study team
  • Lead medical input for scientific publications
  • Collaborate with Regulatory Affairs
  • Contribute to regulatory submissions
  • Contribute to the development of internal processes
Axsome Therapeutics Inc

Axsome Therapeutics Inc

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With a dedicated focus on developing therapies for central nervous system conditions—such as depression, Alzheimer’s disease agitation, and fibromyalgia—this company stands out by addressing critical unmet medical needs with promising products like AXS-05 and AXS-07. The firm fosters a culture deeply committed to innovation and the development of therapies with novel mechanisms of action, showcasing strong potential in the medical field and enhancing patient care in areas with limited treatment options.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

7%

1 year growth

42%

2 year growth

231%