The Associate Director of Clinical Pharmacology role is responsible for clinical pharmacology matters for a range of projects spanning the CSL R&D portfolio. The incumbent will be independent, innovative, solution oriented and matrix team-aligned in the fulfillment of Clinical Pharmacology responsibilities. This includes leading a program's clinical pharmacology & pharmacometrics strategy, ensuring coverage and integrated delivery of all pharmacokinetic and modeling and simulation aspects, and the design of clinical pharmacology studies for multiple programs. In addition, the role will involve key written/oral ClinPharm/Pharmacometric interactions with regulatory authorities, writing of clinical pharmacology sections in the dossiers and answering questions in connection with submission procedures. The industry-experienced person undertaking this role will have excellent pharmacokinetic/pharmacometrics knowledge and will work in close collaboration with non-clinical, Research and all Clinical R&D functions.
Main Responsibilities and Accountabilities
Lead, with a high degree of independence, the clinical pharmacology and PK-PD strategy for portfolio programs, working in conjunction with the Pharmacometrician, Clinical Program Director, Clinical scientists, Biostatisticians, and other CDT colleagues.
Lead the design of clinical pharmacology studies or protocol sections as required throughout all stages of drug development and provide oversight for implementation of such studies together with Clinical Development, Clinical Safety and Clinical Research Operations.
Independently plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and relevant PK-PD analysis as required.
For a MD, be able to provide medical expertise, input and/or oversight to Clinical Pharmacology studies.
Independently undertake and/or lead the high quality review and interpretation of clinical pharmacology study results and oversees the presentation thereof in clinical study reports, publications and related study documentation.
Independently provide clinical pharmacology & pharmacometrics representation on clinical development matrix teams, ensuring cross-functional alignment and integration of the clinical pharmacology strategy within the global development plan.
Independently implement the use of innovative analytical methods such as pharmacometrics/modeling & simulation to integrate knowledge of pharmacokinetics, pharmacodynamics, patient characteristics and disease states in support of optimal study designs throughout an assigned clinical development program.
Provide effective clinical pharmacology contributions to protocols, regulatory documents including Investigator Brochures, Labelling and those required for face to face attendance at regulatory meetings and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, independently taking a lead role in setting strategy to and writing responses to regulatory queries.
Represent, with minimal managerial guidance/support, Clinical Pharmacology for market approval submissions to regulatory authorities, authority meetings and answers to all related authority questions.
Be able to provide independent support to Research and Translational Science and in the development of preclinical PK-PD knowledge required for early clinical development strategy, as well as utilizing Pharm-Tox data appropriately in the development of early clinical studies.
Establish and maintain networks of external thought/opinion leaders in the clinical pharmacology field.
Position Qualifications and Experience Requirements
PhD/PharmD or recognized medical degree(MD).
Clinical pharmacology research fellowship favorable.
For a MD candidate, ideally, be board-specialized in clinical pharmacology or another medical specialty, or for a non-MD, have extensive experience in a clinical pharmacology discipline (e.g., PK-PD).
A minimum 2 years pharmaceutical industry (or relevant) experience for MD candidates or 5 years for candidates with PhD/PharmD, specifically contributing to the clinical pharmacology aspects of clinical drug development.
Advanced understanding of general clinical pharmacology (including the design and conduct of clinical trials), interpretation of PK, PK-PD, population PK methodologies and related data interpretation, and the use of biomarkers in clinical development.
For non-MDs, proven technical ability in pharmacometrics methodology and application.
Excellent communication skills with demonstrated ability to effectively present clinical pharmacology data, development plans and strategies to various audiences in both verbal and written form.
Excellent oral presentation and writing skills.
Ability to create and communicate clinical pharmacology programs.
Ability to create publications according to international scientific standards.
Excellent interpersonal skills, including a positive and constructive attitude and ability to effectively work in a project matrix environment. Negotiation and influential skills advantageous.
Experience working in multi-functional teams and ability to work collaboratively within matrix management environments.
Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications.
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