Senior/Principal Scientist, Clinical Pharmacology

About the role

Roche is hiring a Senior/Principal Clinical Pharmacology Scientist in Shanghai. The scientist develops and implements quantitative clinical pharmacology strategies across early to late phase clinical drug development, using modeling and simulation tools to help choose the right drug, dose and regimen for patients. The role is an active member of cross-functional drug development teams and represents the CP function on filing teams and with regulatory agencies.

Key responsibilities

• Lead the design and review of clinical study protocols for novel therapeutic agents, with particular focus on China development (all drug and delivery modalities)
• Plan and conduct PK/PD data analyses and set the strategy for using modeling and simulation to inform clinical decisions
• Represent CP at internal and external China-focused meetings, including cross-functional teams, governance reviews and scientific conferences
• Manage project priorities to align CP deliverables with changing regulatory and project needs in China
• Write regulatory documents and meeting background packages for key clinical milestones in China
• Lead CP representation at health-authority meetings in China and contribute to planning and organizing regulatory filings (IND, BLA, NDA, sNDA)
• Support global clinical pharmacology and M&S development strategies as needed

Required profile

• PhD, PharmD, MD or equivalent in Pharmacokinetics, Pharmaceutical Sciences or a related quantitative discipline
• Experience showing strong leadership and the ability to represent CP in cross-functional project teams
• Good knowledge of GCP and working knowledge of relevant regulatory guidelines
• Excellent written and oral communication skills for protocols, publications, regulatory documents and stakeholder engagement

Required skills

• Ability to plan, organize, interpret and perform PK/PD data analyses
• Familiarity with clinical study design for different drug and delivery modalities
• Quantitative modeling approaches and working knowledge of software such as NONMEM, WinNonlin, R, SimCYP, GastroPlus, PKSim and Matlab
• Agentic approaches for workflow integration and efficiency
• Statistical approaches applied to clinical study design and analysis
• Desired: experience leading regulatory filing strategy, dose/regimen justification and drug labeling