Immunology Development Clinical Research Physician Medical Director
This is a permanent role with hybrid working. As Development Clinical Research Physician you will participate in the development, conduct, and reporting of corporate/global clinical trials in support of registration and commercialisation of Immunology products.
Responsibilities:
1. Collaborate in 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.
2. Contribute to the global alignment of clinical strategy and clinical plans.
3. Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.
4. Plan collaborate on and review the scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (for example, annual reports) according to the agreed-upon project timeline.
5. Provide oversight and input into Inform Consent Documents.
6. Collaborate with clinical research staff in the design, conduct, and report of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).
7. Review and approve risk profiles to ensure appropriate communication of risk to study subjects.
8. Participate in investigator identification and selection, in conjunction with clinical teams.
9. 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.
10. 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.
11. Serve as a resource to clinical operations personnel/clinical research monitors, investigators, and ethical review boards to address any questions or clarify issues arising during the conduct of the study.
12. Understand and actively address the scientific information needs of all investigators and personnel.
13. Monitor patient safety during the conduct of studies and conduct the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.
14. Review IIT proposals and publications, as requested.
15. Knowledge of and compliance with local laws and regulations, global policies and procedures, compliance guidelines concerning data dissemination, and interactions with external healthcare professionals.
16. Understand and actively address the unsolicited scientific information needs of external healthcare professionals according to the guidelines above.
17. Participate in reporting clinical trial data in Clinical Trial Registry activities.
18. Support the planning of symposia, advisory board meetings, and other meetings with healthcare professionals.
19. Support medical information associates in the preparation and review of medical letters and other medical information materials.
20. Prepare or review scientific information in response to customer questions or media requests.
21. Provide telephone follow-up or specific written information requested by healthcare professionals as per global SOPs.
22. Support data analysis and the development of slide sets (through reviewing and/or approving) and publications (abstracts, posters, manuscripts).
23. Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional, and possibly international basis.
24. Develop and maintain appropriate collaborations and relationships with relevant professional societies.
25. Support the design of customer research as a medical expert.
26. Support training of medical personnel, including geographic/affiliate CRPs, medical and outcome liaisons, and global patient outcomes personnel.
27. Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.
28. Participate in the development and review of label changes and labelling modifications in collaboration with affiliates, brand teams, regulatory, and legal.
29. Provide medical expertise to regulatory scientists.
30. Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports, and Periodic Adverse Drug Experience reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.
31. Participate in advisory committees.
32. Participate in risk management planning along with affiliates and Global Patient Safety (GPS).
33. Critically read and evaluate the relevant medical literature; know the status and data from competitive products and keep updated with medical and other scientific developments relevant to the product.
34. Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product, both near-term (1-2 years) and longer-term (3-5years).
35. Responsible for the scientific training of the clinical study team.