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Clinical Pharmacology Director
4 weeks ago
About Haleon
Haleon is a world-leading consumer health company that is shaping the future of everyday health for billions of people. Our portfolio of category-leading brands, including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum, is built on trusted science and human understanding. We're committed to growing and innovating our business through a unique combination of deep human understanding and trusted science.
About the Role
The Associate Director, Clinical Pharmacology is a key member of our clinical research team, 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 and the ability to provide high-quality contributions to meet state-of-the-art scientific, industry, and regulatory standards.
Key Responsibilities
- Provide clinical pharmacology contributions, including biowaiver assessments, and author the clinical development plan.
- Prepare, review, and contribute to clinical study protocols.
- Review and contribute to key study documents, such as the Investigator's Brochure, Statistical Analysis Plan, Analytical Method plan & validations, and Bioanalytical documentation.
- Review and contribute to the preparation of the Investigator's Brochure and clinical study reports, CTD modules, answers to HA questions.
- Supervise study setup and execution, including Kick-off meetings, Site Initiation Visits, regular team meetings, risk management processes, issues escalation, management of protocol deviations, and blind data review.
- Collaborate with Biostatisticians to provide and review clinical trial data for disclosure activities.
Requirements
- Bachelor's Degree in Life Science, Clinical Pharmacology, or Pharmacokinetics.
- Minimum 8 years of pharmacokinetics experience.
- Experience working in the pharmaceutical industry or CRO.
- Solid understanding of clinical drug development.
- Proven ability to effectively liaise and influence internally and externally.
- Ability to work in a multi-functional team.
- Ability to handle issues with initiative and integrity.
Preferred Qualifications
- Advanced Scientific degree, such as a PhD.
- Knowledge of bioanalytical science is preferred.
- Excellent communication and computer skills.
- English: fluency oral and written.
- Bi-lingual in French.
About Haleon's Culture
Haleon is an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.
Equal Opportunity Employer
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status, or any other federal, state, or local protected class.
