Clinical Scientist / Senior Clinical Scientist - Autoimmune

at  Autolus Ltd

Role Summary
The current position will be in clinical development in the area of Autoimmune Advanced Therapy Investigational Medicinal Products (ATIMPs). The Clinical Scientist (Senior Manager) using clinical, scientific and technical disciplines supports high quality protocol development, study execution and data interpretation. They will be responsible for supporting the Lead Clinical Scientist with clinical deliverables on one or more interventional clinical trials. The Clinical Scientist (Senior) Manager is a key member of the study team and partners closely with the clinicianand clinical operations team members, applying technical and scientific excellence to support the development and execution of clinical trials to meet the needs of internal and external customers. Clinical scientist responsibilities impact key elements of the study lifecycle including protocol development, safety and quality data review, patient narratives and Clinical Study Report (CSR) development.

Key Responsibilities

• Provides support in the writing of protocol outlines, protocols, and amendments in collaboration with the Clinician, Translational Medicine, Clinical Operations, and other relevant groups.
• Ensures appropriate CRF design and implementation.
• Partners with data management to develop data review plan for review of data.
• With supportfrom the Lead Clinical Scientist,the Clinical Scientist(Senior Manager) will review all patientlevel 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.
• Collaborates 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.
• Developsspecificmedical/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.

Demonstrated skills and competencies E – Essential P – Preferred Experience

• Experience in the field of drug development of Multiple Sclerosis is highly 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 ispreferred.
• 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 • 5+ 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

• Provides support in the writing of protocol outlines, protocols, and amendments in collaboration with the Clinician, Translational Medicine, Clinical Operations, and other relevant groups.
• Ensures appropriate CRF design and implementation.
• Partners with data management to develop data review plan for review of data.
• With supportfrom the Lead Clinical Scientist,the Clinical Scientist(Senior Manager) will review all patientlevel 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.
• Collaborates 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.
• Developsspecificmedical/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