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Clinical Pharmacology Director
1 month ago
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Associate Director, Clinical Pharmacology Expert
2 months ago
About the Role
The Associate Director, Clinical Pharmacology is a key position within Haleon, responsible for leading clinical research activities with a focus on clinical pharmacology phase I pharmacokinetics and bioequivalence trials. This role requires a high level of expertise in clinical pharmacology, ensuring that high-quality contributions are provided to meet state-of-the-art scientific, industry, and regulatory standards.
Key Responsibilities
- Provide clinical pharmacology contributions, including biowaiver assessments, to support clinical development plans.
- Prepare, review, and contribute to clinical study protocols, ensuring they meet regulatory requirements.
- Review and contribute to key study documents, including ICFs, Statistical Analysis Plans, Analytical Method plans, and Bioanalytical documentation.
- Lead the preparation of Investigator's Brochures, clinical study reports, CTD modules, and responses to HA questions.
- Supervise study setup and execution, including site initiation visits, risk management, and protocol deviations.
- Collaborate with Biostatisticians to provide clinical trial data for disclosure activities.
Requirements
- Bachelor's Degree in Life Science, Clinical Pharmacology, or Pharmacokinetics.
- Minimum 8 years of pharmacokinetics experience, preferably in the pharmaceutical industry or CRO.
- Solid understanding of clinical drug development and ability to effectively liaise and influence internally and externally.
- Ability to work in a multi-functional team and handle issues with initiative and integrity.
Preferred Qualifications
- Advanced Scientific degree, such as a PhD.
- Knowledge of bioanalytical science and excellent communication and computer skills.
- Fluency in English, both written and spoken, and bi-lingual in French.
