Clinical Strategy Consultant
WuXi Biologics · United States · 3 mo ago
RemoteRemoteHealthcareContract
Job Responsibilities
- Clinical Advisory
- Advise on Phase I/II trial design (dose escalation, endpoints, I/E criteria)
- Guide medical monitoring (SAE review, dose rules)
- Translate clinical supply needs (batch size, stability) into internal manufacturing considerations
- Ensure nonclinical programs (GLP toxicology, species, starting dose like MABEL/NOAEL) enable clinical entry
- Review data to identify risks (e.g., cytokine release) and mitigation strategies
- CRO Negotiation (Client Representation)
- Evaluate proposals, protocols, and ICFs
- Provide oversight – attend investigator meetings, review clinical data, interpret safety/efficacy results
- Ensure CRO deliverables meet expectations
- Internal Bridge (Manufacturing → Clinical Trials)
- Work with internal CMC teams to ensure clinical batch production meets study needs
- Advisory on comparability strategies when manufacturing changes
- Bid Development, Client Engagement & Knowledge
- Support client presentations and bid defenses
- Identify clinical red flags in early-stage projects
- Track trial design trends (adaptive, biomarker-driven)
- Maintain regulatory awareness (FDA, EMA, NMPA) on endpoints and safety reporting
- Education & Experience
- MD (board certification in oncology/rheumatology/neurology/immunology strongly preferred)
- 10+ years in biopharma/clinical research, with ≥3 years direct clinical development (medical monitor, clinical scientist, or CRO advisor), preferably in leading Phase 1 trials in China and/or Australia
- Proven CRO negotiation experience (sponsor/client side). Prior CRO/CDMO/clinical consulting highly desirable
- Deep understanding of large-molecule clinical & nonclinical development (immunogenicity, PK/PD)
- Mandarin language preferred
- Core Skills
- Hands-on: Phase I/II design, protocol writing, medical monitoring, safety data review (SAE/SUSAR)
- Experience of leading Phase 1 trials in China and/or Australia is a big plus
- Interpret clinical data & nonclinical toxicology reports; translate to manufacturing
- Strong negotiation & vendor management; excellent client communication (trusted partner); fluent English