Director of Clinical Strategy

Job Responsibilities

1. 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.
2. 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.
3. Internal Bridge (Manufacturing → Clinical Trials)
• Work with internal CMC teams to ensure clinical batch production meets study needs (dose strength, blinding, stability).
• Advisory on comparability strategies when manufacturing changes.
4. 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.

Qualifications

• 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).
• 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).