Senior/Principal Scientist, Clinical Pharmacology
Roche · Shanghai
Job description
About the role
The Clinical Pharmacology Scientist at Roche will lead quantitative pharmacology strategies across all phases of drug development, ensuring optimal dosing and therapeutic benefit for patients. The role focuses heavily on China‑centric development, collaborating with cross‑functional teams to drive model‑informed decisions.
Key responsibilities
- Lead design and review of clinical study protocols for novel therapeutics, with a primary focus on China development.
- Plan, conduct, and interpret PK/PD data analyses and guide the use of modeling and simulation to support development decisions.
- Represent the Clinical Pharmacology function in internal and external meetings, including cross‑functional teams, governance reviews, and scientific conferences.
- Manage project timelines and align CP deliverables with evolving regulatory requirements in China.
- Author regulatory documents and meeting packages to support key clinical milestones.
- Lead CP interactions with Chinese health‑authority bodies and contribute to IND, BLA, NDA, and sNDA filings.
- Support global clinical pharmacology and modeling & simulation strategies as needed.
Required profile
- Proven ability to plan, organize, interpret, and perform PK/PD data analyses.
- Strong familiarity with clinical drug development processes and study design options.
- Experience working on China‑focused drug development projects.
- Excellent communication skills for cross‑functional and regulatory interactions.
Required skills
- PK/PD data analysis
- Pharmacokinetic/pharmacodynamic modeling and simulation
- Clinical study protocol design
- Regulatory document preparation (IND, BLA, NDA, sNDA)
- Project management in a drug development context
What we offer
- Opportunity to work at a global leader in healthcare innovation.
- Collaborative environment with multidisciplinary experts.
- Impactful work shaping drug development for patients worldwide.
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Roche
Shanghai