JOB SUMMARY
Axsome Therapeutics is seeking a Clinical Research Scientist or Sr. Clinical Research Scientist (based on experience) that reports to the Clinical R&D function, serves as a critical asset to the Clinical Lead and supports the design and delivery of our clinical trials. The CRS is responsible for the implementation, planning and execution of assigned clinical trial activities and serves as the Clinical Trial Lead for multiple studies. The Clinical Research Scientist will independently lead, plan and execute trial and compound level activities.
This is a hybrid role based at Axsome’s HQ in New York City.
JOB 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).
QUALIFICATIONS/REQUIREMENTS
- Advanced degree (Pharm.D., MPH, PhD, MS) with 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
SALARY & BENEFITS
The anticipated salary range for this role is $123,000 - $145,000. 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.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
