This role advises clients on early-stage clinical development for large molecules, including Phase I/II study design, dose escalation, endpoints, eligibility criteria, and medical monitoring. It also reviews nonclinical toxicology data to support clinical entry and helps translate clinical needs into manufacturing and supply considerations. The work is remote and includes client-facing strategy, CRO oversight, and cross-functional collaboration with internal clinical and CMC teams.
Key Responsibilities
- Advise on Phase I/II trial design, including dose escalation strategy, endpoints, and inclusion/exclusion criteria.
- Provide medical monitoring guidance, including SAE review, safety assessment, and dose decision support.
- Review nonclinical data such as GLP toxicology, species selection, and starting dose rationale to support first-in-human entry.
- Translate clinical supply requirements into manufacturing considerations, including batch size, stability, and blinding.
- Lead scope, budget, and contract negotiations with clinical and nonclinical CROs on behalf of clients.
- Evaluate protocols, proposals, informed consent forms, and CRO deliverables for clinical and safety adequacy.
- Attend investigator meetings and interpret safety and efficacy data to identify study risks and mitigation strategies.
- Support client presentations, bid defenses, and early project assessments for clinical red flags.
Required
- MD degree.
- Board certification in oncology, rheumatology, neurology, or immunology strongly preferred.
- At least 10 years of experience in biopharma or clinical research.
- At least 3 years of direct clinical development experience, such as medical monitor, clinical scientist, or CRO advisor.
- Experience with CRO negotiation from the sponsor or client side.
- Strong understanding of large-molecule clinical and nonclinical development, including immunogenicity and PK/PD.
Preferred
- Experience leading Phase 1 trials in China and/or Australia.
- Prior experience in CRO, CDMO, or clinical consulting roles.
- Mandarin language proficiency.
- Experience with regulatory interactions such as pre-IND or EOP2 meetings.
- Experience with clinical supply logistics, including labeling, cold chain, and distribution.
Benefits & Perks
- Remote work.