Senior Clinical Pharmacology Director
4 weeks ago
Haleon: A New Era in Consumer Health
We are shaping the future of consumer health at Haleon, a world-leading company. Our mission is to improve everyday health for billions of people. We achieve this by growing and innovating our global portfolio of category-leading brands, such as Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum, through a unique combination of deep human understanding and trusted science.
As a key member of our team, you will contribute to our success by leading clinical research activities with a focus on clinical pharmacology phase I pharmacokinetics and bioequivalence trials. You will ensure that high-quality expertise is provided to meet state-of-the-art scientific, industry, and regulatory standards.
Key Responsibilities:
- Provide clinical pharmacology contributions, including biowaiver assessments, or 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.
- Lead 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.
About Haleon:
We are 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.
We strive 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.
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