[Remote] Clinical Strategy Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Director of Clinical Strategy who will serve as the company’s clinical and medical expert for client projects. The role involves advising on clinical development, study design, and medical monitoring, as well as representing clients in CRO negotiations and ensuring that clinical needs align with internal development and manufacturing.

Responsibilities

• Advise on Phase I/II trial design (reputed company escalation, endpoints, I/E criteria) for large molecules (mAbs, ADCs, bispecifics, fusion proteins). Guide medical monitoring (SAE review, reputed company rules). Translate clinical supply needs (batch size, stability) into internal manufacturing considerations. Ensure nonclinical programs (GLP toxicology, species, starting reputed company like MABEL/NOAEL) reputed company clinical entry; review data to identify risks (e.g., cytokine release) and mitigation strategies
• reputed company scope, budget, and contract negotiations with clinical/nonclinical CROs on behalf of clients. Evaluate proposals, protocols, and ICFs. reputed company reputed company – 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 (reputed company strength, blinding, stability). Advise on comparability strategies reputed company 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

• 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 reputed company)
• 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
• MD (board certification in oncology/rheumatology/neurology/immunology strongly preferred)
• Mandarin language preferred
• Regulatory interactions (pre-IND, EOP2)
• Clinical supply logistics (labeling, cold chain, distribution)

Company Overview

Company H1B Sponsorship