[Remote] Clinical Strategy Consultant
Note: The job is a remote job and is open to candidates in USA. WuXi Biologics is seeking a Clinical Strategy Consultant who will serve as the company's clinical and medical expert for client projects. This role involves advising on clinical development, study design, and medical monitoring while representing clients in CRO negotiations and bridging clinical needs with internal development and manufacturing.
Responsibilities
- Advise on Phase I/II trial design (dose escalation, endpoints, I/E criteria) for large molecules (mAbs, ADCs, bispecifics, fusion proteins). 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
- Lead scope, budget, and contract negotiations with clinical/nonclinical CROs on behalf of clients. Evaluate proposals, protocols, and ICFs. Provide oversight – attend investigator meetings, review clinical data, interpret safety/efficacy results, ensure CRO deliverables meet expectations
- Work with internal CMC teams to ensure clinical batch production meets study needs (dose strength, blinding, stability). Advise on comparability strategies when manufacturing changes
- 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
Skills
- MD (board certification in oncology/rheumatology/neurology/immunology strongly preferred)
- 5–8 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)
- Deep understanding of large-molecule clinical & nonclinical development (immunogenicity, PK/PD)
- Hands-on: Phase I/II design, protocol writing, medical monitoring, safety data review (SAE/SUSAR)
- Interpret clinical data & nonclinical toxicology reports; translate to manufacturing
- Strong negotiation & vendor management; excellent client communication (trusted partner); fluent English
- Prior CRO/CDMO/clinical consulting highly desirable
- Experience of leading Phase 1 trials in China and/or Australia is a big plus
- Regulatory interactions (pre-IND, EOP2)
- Clinical supply logistics (labeling, cold chain, distribution)
Company Overview
Company H1B Sponsorship