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Clinical Scientist

1 month ago

London, Greater London, United Kingdom Skills Alliance Full time
Job Title: Clinical Scientist

We are seeking a highly skilled Clinical Scientist to join our team at Skills Alliance. As a Clinical Scientist, you will play a key role in supporting the development and execution of clinical trials in the field of oncology drug development.

Key Responsibilities:
  • Provide support in the writing of protocol outlines, protocols, and amendments in collaboration with the Clinician, Translational Medicine, Clinical Operations, and other relevant groups.
  • Ensure appropriate CRF design and implementation.
  • Partner with data management to develop data review plan for review of data.
  • Review all patient level and cumulative data per the data review plan.
  • Review in detail electronic Case Report Forms (eCRFs) for all patient data as well as non-CRF data types (eg translational data).
  • Reviews safety data, SAE reports and ensures clinical documents are updated as required.
  • Provide input to data packages for program or company level safety meetings.
  • Provide input to protocol deviation reporting and reviews.
  • Collaborate with Lead Clinical Scientist to provide medical/scientific guidance during the execution of the study.
  • May perform and coordinate clinical sciences deliverables across studies at the program level.
  • Ensures TMF compliance for clinical sciences study level TMF documents.
  • Answers specific site protocol questions as needed.
  • Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, and for Autolus site facing roles and vendor / CRO staff.
  • Identifies scientific quality issues to discuss with study team members so that corrective actions may be instituted.
  • Escalates protocol-related issues requiring complex medical expertise to the Clinician.
  • Escalates operational issues to the appropriate operations study team member.
  • Provides scientific input to and review of CSRs including writing of narratives.
  • May support and contribute to various sections of regulatory documents (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses).
  • Identifies, significantly contributes to, or leads continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
  • Support, organize Investigator meeting, scientific advisory boards, regulatory meeting and other program or company specific activities as needed.
  • Participate in organizational initiatives.
Requirements:
  • Experience in the field of oncology drug development is required.
  • Experience in the field of drug development of Diffuse Large B Cell Lymphoma (DLBCL) and B Cell Acute Lymphoblastic Leukemia (B-ALL) (adult and/or pediatrics) is preferred.
  • Experience in the field of CAR T drug development is preferred
  • Experience in execution of clinical trials, including data review and investigative site relations is preferred.
  • Proven ability to get results in a matrixed management environment.
  • Should be experience and comfortable in a fast-paced entrepreneurial and dynamic setting across multiple jurisdictions.
  • Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data.
  • Practical experience in clinical trial strategies, methods and processes is preferred.
  • Track record of design, oversight and interpretation of scientific data and/or clinical studies.
  • Significant experience in development and implementation of clinical research protocols is preferred.
  • The individual must have demonstrated ability to work in a matrix team environment.
  • The willingness to travel up to 20% of the time is required.
Qualifications:
  • An advanced degree such as a Ph.D., M.D or Pharm.D or equivalent is preferred
  • 3+ (Clinical Scientist) - 5+(Senior Clinial Scientist) years' experience as Clinical Scientist within the pharmaceutical industry or academia is preferred.
Skills:
  • The role requires a high-performing and energetic individual who demonstrates outstanding scientific knowledge and the highest personal and ethical standards.
  • Significant knowledge of basic and clinical cancer research and its application to cancer drug development is important.
  • A knowledge of the key areas of early drug development, including chemistry, biology, toxicology and early clinical development is required.
  • Basic understanding of local / international regulations applicable to clinical trials.
  • Knowledge and experience in Good Clinical Practices.
  • Working knowledge of statistics, data analysis, and data interpretation.
  • Demonstrated ability to influence and lead.
  • Problem solving and challenging existing convention when appropriate are second nature.
  • Ability to strategize and lead a goal oriented clinical development team will be very valuable