Senior Clinical Pharmacology Specialist
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About The Position
The Clinical Pharmacology Specialist is responsible for developing and implementing the clinical pharmacology strategy for phases 1-4 of clinical development programs. This includes establishing dosage and administration strategies, which encompass dose setting and dosing regimens for various projects. The role requires a deep understanding of the scientific and pharmacological aspects of clinical trials, as well as the ability to share knowledge as an expert in clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and dosage administration. This position is highly collaborative and cross-functional, necessitating interaction with various teams including Medical Specialists, Clinical Operations, Medical Writing, Regulatory Affairs, Data Science, and Global Medical Affairs. The Clinical Pharmacology Specialist will also be involved in negotiating clinical pharmacology aspects at internal and external meetings, including those with regulatory authorities and advisory boards. In addition to strategic responsibilities, the Clinical Pharmacology Specialist will ensure the scientific quality of critical documents such as the Clinical Pharmacology Summary, Investigator's Brochure, and other materials required for Health Authority interactions. The role also involves designing clinical pharmacology trials that align with the overall strategy and ensuring that the trial design is scientifically sound and cost-effective. The Specialist will be responsible for the assessment, evaluation, and interpretation of scientific data throughout the trial process, ensuring that all activities are aligned with the clinical pharmacology strategy and the needs of relevant stakeholders. The position requires a commitment to knowledge-sharing and the development of competencies in clinical pharmacology, PK/PD, and dosing strategies. The Specialist will prepare and present publications, interpret external and competitor data, and maintain an external network of advisors, including key opinion leaders and research scientists. This role is pivotal in supporting the development of innovative treatment modalities and ensuring that the clinical development programs are scientifically robust and aligned with commercial aspirations.
