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Senior Clinical Pharmacology and Biopharmaceutics Lead
2 months ago
We are seeking a highly experienced and accomplished Clinical Pharmacology Director and PBPK Specialist to join our team at The RFT Group. As a key member of our BioPharmaceutical Division, you will be responsible for leading clinical pharmacology and PBPK initiatives, ensuring the scientific quality of clinical studies, and collaborating with cross-functional teams to drive development decisions.
Key Responsibilities- Leadership and Expertise: Provide strategic guidance on clinical pharmacology matters, support project teams, and ensure the scientific quality of clinical studies.
- Study Design and Conduct: Design, implement, analyze, interpret, and report clinical pharmacology studies, ensuring adherence to regulatory requirements and timelines.
- Collaboration and Communication: Integrate clinical pharmacology knowledge with related disciplines, such as clinical, statistics, regulatory, and nonclinical ADME, to support development decisions. Effectively communicate pharmacokinetic concepts to diverse audiences.
- Regulatory Interactions: Contribute to the development of high-quality clinical pharmacology plans and content for global regulatory documents, including protocols, investigator's brochures, briefing documents, and IND applications.
- Team Management: Oversee clinical pharmacology and PBPK consultants, maintain relationships with contract vendors, and ensure the timely and accurate execution of deliverables.
- Scientific Publishing: Present data at scientific meetings, author/review manuscripts for submission to peer-reviewed journals, and contribute to the production of scientific documents.
- Education: PhD or PharmD degree with emphasis in clinical pharmacology and experience with clinical pharmacology studies.
- Experience: Several years of scientific, strategic, and operational experience in planning, executing, reporting, and publishing clinical PK/PD programs in CNS pharma.
- Skills: Excellent understanding of ICH GCP, strong quantitative skills, ability to critically analyze problems, and scientific rigor in experimental design and study conduct.
- Leadership and Collaboration: Demonstrated ability to work effectively in a matrixed team environment, manage multiple priorities, and exercise sound judgment. Experience in managing outsourced development programs and working cross-functionally.
