The Principal Scientist will be the PKDM Development Project Team Representative on the Early and/or Global Development Teams in the area of Oncology. He/she will support small and large molecule drug development, registration, and post-marketing activities. He/she will be responsible for program-level strategic and resource planning, communication, scientific/technical deliverables, issue resolution, and functional representation for internal governance reviews, face-to-face interactions with global regulatory authorities, and external scientific communities. The individual will effectively lead PKDM Development Project Team, and interface with internal business stakeholders (such as Clinical Development, Early Development, Biostatistics, Regulatory Affairs, Research, Toxicology, etc.). This PKDM Development Project Team Reprehensive will be responsible for the PK, PK/PD, and Modeling & Simulation strategy in the Early and Global Development Teams, prepare regulatory documents as a PK/PD expert, and represent PKDM Department in the global regulatory interactions. Development of junior members and interaction with the line-management will also be key responsibilities.
Preferred Qualifications - PhD (or MS/BS with equivalent experience) in PK, Pharmaceutical Sciences, Engineering, Pharmacology, Biostatistics, Life Sciences or with equivalent professional degrees (e.g. MD, PharmD) with 7+ years experience in the Biotechnology/Pharmaceutical Industry or post-doctoral training is required
- Established track-record as a PKDM and/or Clinical Pharmacology functional representative on product development team(s) in Oncology with working knowledge in bioanalytical and drug metabolism
- Experience in PK/PD modeling and population-based analyses/simulations (e.g. hands-on experience for software such as NONMEM, S-PLUS, Clinical Trial Simulator, etc) and PK analysis (e.g. proficiency in WinNONLIN)
- Experience in authoring regulatory documentations (IND, IMPD, CTX, RTQ, CTD, etc), knowledge in global regulatory requirement and guidance, and interaction with global health authorities
- Leadership quality for effective team building with strong decision making and problem solving skills
- Excellent interpersonal, technical, and communication skills that enable effective management and resolution of complex issues involving collaborations within a cross-functional team setting
- Project management skills for timeline tracking and resource planning
- Comprehensions in R&D processes for small molecules and/or protein therapeutics. General understanding in biology (mechanism of action)/pharmacology, toxicology, clinical immunology, protein sciences, statistics, pharmaceutics, and clinical development, etc.
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