Associate Director​/Director-Global Clinical Pharmacology

Associate Director/Director-Global Clinical Pharmacology

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• Associate Director/Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects
• Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards
• The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions

• Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio
• Provide scientific insights that drive global clinical development decisions and support global regulatory submissions
• Responsible for ensuring appropriate Clinical Pharmacology representation on drug/dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project
• The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed
• Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting)
• Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies
• Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first-in-human studies and dosage regimens in patients
• Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs
• During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first-in-man studies
• Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies
• Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study
• Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign‑off. Assist with internal and external dissemination of results to Development Team, Investigators etc.
• Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling
• Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design
• Participates in multidisciplinary teams in assessing potential in‑licensing opportunities, as requested by line management
• Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies
• Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders

• PhD in…