Full-Time

Clinical Research Scientist/Sr. Clinical Research Scientist

Axsome Therapeutics Inc

Axsome Therapeutics Inc

501-1,000 employees

Develops novel therapies for central nervous system conditions.

Biotechnology

$123,000 - $145,000

Bonus, Equity

Senior

New York, NY, USA

Required Skills
Communications
Google Cloud Platform
Requirements
  • Advanced degree (Pharm.D., MPH, PhD, MS)
  • At least 5 (Assoc. Dir.) or 8 (Dir.) years of clinical development experience at a pharmaceutical company
  • Experience writing and reviewing clinical documents (eg, protocols, CSRs, IBs, DSURs). Experience with regulatory documents (INDs, briefing books, NDAs)
  • Strong analytical skills with excellent communication (both oral and written)
  • Ability to assimilate technical information quickly
  • Routinely takes initiative
  • Detail-oriented
  • Strong sense of teamwork; ability to lead team activities
  • Proficient in Medical Terminology and medical writing skills
  • Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study (including MOA, PK/PD, biomarker & safety profile)
  • Proficient critical thinking, problem solving, decision making skills
  • Thorough understanding of FDA, GCP and ICH guidelines
  • Comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
  • Excellent team player; willingness and ability to fill functional gaps in a small but growing organization
  • Preference to energetic candidates with a desire to think \
  • outside the box\
  • Proficiency with MS Office suite, Electronic Data Capture, and other reporting tools
  • Willingness to travel as needed, up to 20%
  • Ability to work on site Monday, Tuesday and Thursday
Responsibilities
  • Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members
  • Plan and lead the implementation all study startup/conduct/close-out activities as applicable
  • Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical R & D Lead)
  • Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross functional comments and ensuring high clinical quality
  • Co-lead study team meetings in partnership with Clinical Operations and collaborates with cross-functional study team members (e.g., Regulatory Affairs, Safety, Data Management).
  • Partner with the Clinical Trial Manager and Study Director to support the overall execution of a clinical studies.
  • Perform regular data reviews to identify trends.
  • Support medical data review and medical coding review.
  • Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on study committee (e.g., DMC) activities
  • Draft/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses)
  • Collaborate and serve as primary liaison between external partners for scientific advice
  • Facilitate development of case report forms.
  • Support SAE process, query generation, narrative development and review.
  • Support labelling, distribution, and overall accountability of Clinical trial material (CTM) for the clinical study, as needed.
  • Support the review and revision of Standard Operating Procedures (SOPs).
  • Assist in the preparation of abstracts, poster presentations, slides, and manuscripts of clinical study findings.
  • Attend relevant therapeutic area conferences/meetings based on assignments and engages KOLs.
  • Support review of proposed investigator-sponsored research (ISR).

Axsome Therapeutics Inc

Axsome Therapeutics Inc

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Axsome Therapeutics, Inc. stands out as a leader in the biopharmaceutical industry due to its dedicated focus on developing novel therapies for central nervous system conditions, an area with limited treatment options. The company's commitment to creating products that significantly improve patient lives demonstrates a strong, patient-centered culture. Its unique approach to treating CNS conditions through the development of therapeutic options with novel mechanisms of action showcases its technical innovation and competitive edge in the industry.

Company Stage

IPO

Total Funding

$430.7M

Headquarters

New York, New York

Founded

2012

Growth & Insights
Headcount

6 month growth

22%

1 year growth

48%

2 year growth

399%