Description:
Through the application of scientific training and clinical training and expertise, the Development clinical research scientist participates in: the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialization of the product; the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety; the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts; contacts with regulatory and other governmental agencies; outreach medical activities aimed at the external clinical customer community, including thought leaders; the development and implementation of the business unit and global strategy for the product; and various medical activities in support of demand realization.
The clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities comply with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP, etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds.
Clinical Planning
- Collaborate with the development and maintenance of a Draft Launch Label and Value Proposition that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans, and study protocol design.
- Contribute to the global alignment of clinical strategy and clinical plans
- Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
Clinical Research/Trial Execution and Support
- Plans collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed-upon project timeline.
- Provide protocol oversight and input into informed consent documents.
- Supports the monitoring of patient safety during the study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
- Review and collaborates with Development Medical Director on the approval of risk profiles to ensure appropriate communication of risk to study subjects.
- Participate in investigator identification and selection, in conjunction with clinical teams.
- Ensure that the operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.
- Assist in the planning process and participate in study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.
- Serve as a resource to clinical operations/ clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study.
- Understand and actively address the scientific information needs of all investigators and personnel.
- Review lIT proposals and publications, as requested
Requirements
- 4+ years in the pharmaceutical industry, preferably in a clinical position.
- Specialisation in oncology (4+ years).
- Experience in areas related to drug discovery/ drug development.
- EU Citizenship/ Stamp 4 visa ideally.
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, Ph.D., MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
- Fluent in English, written and verbal communications
- Ability to engage in occasional domestic and international travel to the degree appropriate to support the business of the team.