Clinical Strategy Director
Full-time
GHR Healthcare
Job Summary:
This role serves as the company’s clinical & medical expert for client projects. Advise on clinical development (FIH to PoC), study design, and medical monitoring. Ensure nonclinical programs support clinical entry. Represent clients in CRO negotiations, and bridge clinical needs with internal development and manufacturing. Job Responsibilities
Education & Experience
This role serves as the company’s clinical & medical expert for client projects. Advise on clinical development (FIH to PoC), study design, and medical monitoring. Ensure nonclinical programs support clinical entry. Represent clients in CRO negotiations, and bridge clinical needs with internal development and manufacturing. Job Responsibilities
- Clinical Advisory -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.
- CRO Negotiation (Client Representation) - 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.
- Internal Bridge (Manufacturing ? Clinical Trials) - Work with internal CMC teams to ensure clinical batch production meets study needs (dose strength, blinding, stability). Advise on comparability strategies when manufacturing changes.
- BD, 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).
- 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). Prior CRO/CDMO/clinical consulting highly desirable.
- 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). 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.
- Preferred: Regulatory interactions (pre-IND, EOP2); clinical supply logistics (labeling, cold chain, distribution).
Vacancy posted 1 day ago
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