We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.
About the role
To ensure adequate scientific support for GW clinical development programs, providing expert input into clinical studies, clinical strategy, implementation of the Clinical Development Plan, as well as participation in problem-solving initiatives within development projects.
Development of clinical trial designs, protocols and the clinical aspects of the execution of clinical trials Phases 1-4.
Develop suitable clinical development plans (and clinical portion of Drug Development Plans) to address the global development requirements of GW.
Key contributor to development of clinical strategies for development of compounds.
Key member of the regulatory document preparation and review team.
Works closely with clinical operations in executing clinical trials.
Key contributor in the review and interpretation of clinical trials data and development of associated integrated analyses and label claims.
Stays updated on competitors and changes in the relevant therapeutic areas as appropriate.
Represents GW at professional meetings and with regulatory authorities as required.
Interacts with KOLs across the relevant therapeutic areas as appropriate.
Responsible for maintaining cGxP and H&S knowledge applicable to the job.
Advises on the design and implementation of clinical projects.
Serves as scientific expert for Phase 1-4 studies, including input to protocol development thorough individual study report and integrated regulatory documentation.
Ensure that the overall scientific content of all clinical programs is sound and appropriately integrated with or complementary to development plans to address global GW priorities.
Contributes to clinical development plans (and/or clinical sections of OOPs).
Ensure there is a clear rationale for translation of discovery/pre-clinical and early clinical findings to planned clinical programs; work closely with discovery/pre clinical and regulatory to answer regulatory authority questions on the data supporting CTAs.
Work to secure cross functional alignment and/or transparent discussion of risks associated with clear plans to further investigate and track through clinical development.
Scientific input to protocol development, data analysis, scientific input to regulatory dossiers and writing of clinical documents.
Assisting Clinical Operations with CRO oversight in International Territories.
Therapeutic Area Training for Clinical Operations staff.
Assist with implementing clinical R&D policies, SOPs and related directives in clinical development.
Assists with the data evaluation process for progress reporting and presentations to senior management.
Prepares various official and regulatory documents for regulatory and other agencies, such as safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex safety or efficacy issues.
Contribute and support clinical initiatives to improve the quality and content of all clinical programs as well as the cross functional/organization processes designed to effectively deliver our R&D portfolio. Advises Clinical Operations on the development and evaluation of therapeutic area-specific data quality standards (e.g. edit check specifications, events of special interest).
Carries out their work in a way that will not adversely affect their own, or others', health, safety and security or the environment and reports any shortcomings in GW arrangements.
Educated to a Masters level (MD, PhD or Pharm D advantageous) in a relevant scientific discipline.
In-depth knowledge of Pharmaceutical industry and related business compliance. Five years of prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research.
Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. Knowledge of clinical trial management, data management, and drug development process.
A detailed understanding of human disease, pharmacology.
Experience in therapeutic area.
Record of previous drug approvals.