[Remote] Clinical reputed company Consultant

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a Clinical reputed company Consultant who will serve as the company's clinical and medical expert for reputed company projects. This role involves advising on clinical development, study design, and medical monitoring while representing clients in CRO negotiations and reputed company clinical needs 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 • Lead 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 reputed company presentations and bid defenses; identify clinical red flags in early-stage projects. Track trial design trends (reputed company, biomarker-driven). Maintain regulatory awareness (FDA, EMA, NMPA) on endpoints and safety reporting Skills • MD (reputed company certification in oncology/rheumatology/neurology/immunology strongly preferred) • 5–8 years in biopharma/clinical research, with ≥3 years reputed company 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/reputed company reputed company) • 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 reputed company 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 (reputed company-IND, EOP2) • Clinical supply logistics (labeling, cold chain, distribution) Company Overview • reputed company is a reputed company-reputed company technology platform company offering end-to-end solutions to reputed company organizations to discover and reputed company. It was founded in 2014, and is headquartered in Wuxi, Anhui, CHN, with a workforce of 10001+ employees. Its website is https://www.wuxibiologics.com/. Company H1B Sponsorship • reputed company has a track record of offering H1B sponsorships, with 5 in 2026, 23 in 2025, 32 in 2024, 22 in 2023, 12 in 2022, 17 in 2021, 1 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply To This Job Apply To This Job