Senior Clinical Scientist

Position Details

  • Job Title: Senior Clinical Scientist
  • Location: New York, NY
  • Job Category: Clinical

JOB SUMMARY

The Senior Clinical Scientist will assist the Chief Medical Officer (and/or designated Development Lead) in all areas of clinical development strategy,  study protocol development, ongoing clinical data review, evaluation, documentation and reporting. You will be responsible for all scientific aspects of a study or studies and have a leading role providing clinical science input into regulatory strategy and documents.

KEY RESPONSIBILITIES

  • Assist in scientifically sound development of the clinical portions of an integrated development plan
  • Conduct preclinical, clinical, and safety data reviews and provide clinical science input into program deliverables
  • Represent clinical science at development team meetings, development operations team, or other appropriate forums,
  • Collaborate with functional area leads from CMC, Clinical Operations, Safety, Project Management, Bioanalytical, Regulatory, Statistics, and Safety to ensure clinical strategies defined by executive management are being employed
  • Prepare and conduct clinical science/program relevant slide presentations required by the project or clinical study (Internal data reviews, training CRO, Kick Off meetings, initiative visit etc) ,
  • Serve as a primary point-of-contact for scientific based questions related to your study/program.
  • Liaise with appropriate departments within the development team framework and/or external consultants/CRO to define the timing of discussion with regulatory bodies.
  • Manage extraction and assimilation of data outputs for team review, CMO review, dose escalation meeting, interim analysis and other forums
  • Coordinate and lead relevant interfaces with key consultants and internal team members on regulatory interactions and strategies (e.g., PreIND meetings, IND development plan, protocol design)
  • Actively perform research and review of the scientific literature for the purpose of drawing insights which in turn enable strategies for company programs.
  • Drive team accountability for completion of company goals related to regulatory milestones and other program milestones.
  • Work with statistical functions to ensure accurate completion of the statistical analysis plan and accuracy of table, listing graph outputs (for interim analysis and final TLFs )
  • Coordinate, oversee, and lead medical writing activities (e.g.  clinical study report process) in accordance with program timeliness

QUALIFICATIONS AND EDUCATION REQUIREMENTS

  • Minimum of 6 years clinical science experience in pharma/biotech industry including established track record of success within Phase 1 – III drug development projects
  • Proficient in medical writing.  You have the capability to extract relevant preclinical/clinical data for summation within clinical study reports, IMPDs, investigational brochures, study protocols, and other submission relevant documents
  • Experience in working on a multifunctional clinical development team (or equivalent) and in working in a diverse environment
  • Strong team player, assertive, and able to “wear many hats” as required within a small startup environment where delegation is not an option.
  • Able to evaluate, interpret & synthesize scientific data, you can verbally present and critically discuss clinical trial data in internal and external meetings
  • Strong interpersonal, verbal communication and influencing skills
  • Ability to support and/or coordinate interfaces with external Key Opinion Leads, advisory boards, or other outside entities
  • Well versed and completely familiar with regulatory requirements pertaining to GCP, GLP and GMP.

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