Job Description- Director Clinical Pharmacology
The 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 relevant 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.
- Plan and implement relevant PK-PD analyses, including non-compartmental analysis of PK data and relevant PK-PD analysis as required.
- Lead the high quality review and interpretation of clinical pharmacology study results and oversee the presentation and writing 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, Submissions, Labeling and those required for face to face attendance at regulatory meetings and regulatory filings. Provides resolution of clinical pharmacology queries from regulatory agencies, taking a lead role in setting strategy to and writing responses.
- Provide 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 or PharmD. Clinical pharmacology research fellowship favorable and extensive experience in a clinical pharmacology discipline (e.g., PK-PD).
- A minimum of 8 years (for Director) 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.
- 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.
• 8+ years in leadership role
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About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
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