全职 Chief Medical Officer (CMO) - Vice President -Medical Director 工作, 薪水 up to HKD 70,000, 济元(香港)生命科技有限公司 Hong Kong 公司招聘中 - Ricebowl

Clinical Development & Medical Affairs

Location

Hong Kong

Employment Type

Full-time

Industry

Biotechnology / Cell & Gene Therapy / Oncology

About the Company

Jiyuan Gene Technology is an innovative biotechnology company focused on the development of next-generation cell and gene therapies. Our lead clinical-stage program, CG101, is an off-the-shelf, genetically engineered iPSC-derived immune cell therapy being developed for acute myeloid leukemia (AML).

CG101 is being developed under a U.S. FDA IND through a global clinical development strategy involving the United States, Hong Kong, Mainland China and other international clinical sites.

Celgenyx (Hong Kong) Life Science Technology Limited is a wholly-owned subsidiary of Jiyuan. As part of our global clinical expansion, we are building a Hong Kong-based clinical development and global regulatory platform and are seeking an experienced leader to join our senior management team.

Position Summary

We are seeking an experienced Vice President / Chief Medical Officer / Medical Director, Clinical Development & Medical Affairs to lead the clinical and medical development of CG101 and future cell therapy programs.

The successful candidate will have primary responsibility for clinical development strategy, investigator engagement, medical oversight, clinical trial execution, CRO management, safety review, regulatory interactions and preparation for later-stage global development.

This is a hands-on leadership role. The successful candidate will work directly with investigators and clinical centers in Hong Kong, the United States and Mainland China and will play a key role in advancing CG101 through Phase I, and subsequent Phase II/registration-directed development. The final title will be determined based on the candidate's qualifications and experience.

Key Responsibilities – Clinical Development Strategy

· Lead the global clinical development strategy for CG101 and subsequent cell therapy programs.

· Translate scientific and nonclinical findings into executable clinical development plans.

· Lead dose-escalation, dose-expansion and Phase I/II clinical development strategy.

· Support determination of DLT, MTD/maximum planned dose and RP2D.

· Contribute to global registration strategies involving the U.S. FDA, Hong Kong regulatory authorities, NMPA/CDE and other health authorities.

· Be part of the company’s new product development team with contributions to medical and clinical insight.

Key Responsibilities – Clinical Trial Execution

· Serve as the senior medical lead for global clinical studies.

· Work directly with principal investigators, hematologists, transplant physicians and cellular therapy centers.

· Oversee patient eligibility, protocol implementation and medically significant protocol deviations.

· Review safety data, efficacy data, MRD results, cell kinetics and pharmacodynamic findings.

· Provide medical input into protocol amendments, Investigator's Brochures, informed consent forms, clinical study reports and regulatory submissions.

· Ensure studies are conducted in accordance with ICH GCP, applicable FDA requirements and local regulations.

Key Responsibilities – Medical Monitoring and Safety

· Provide or oversee medical monitoring of clinical studies.

· Review serious adverse events, DLTs and adverse events of special interest.

· Lead assessment of potential cell therapy-related toxicities including CRS, ICANS, GVHD, prolonged cytopenia, infections, organ toxicities and unexpected or prolonged cellular expansion.

· Work with Pharmacovigilance and CRO teams on safety reporting, DSURs and regulatory safety communications.

· Coordinate with the independent Safety Monitoring Committee / DSMB and prepare clinical safety packages for dose-escalation decisions.

Key Responsibilities – Investigator, CRO and Regulatory Leadership

· Develop and maintain relationships with leading AML and cellular therapy investigators in Hong Kong, the United States, Mainland China and other markets.

· Lead investigator meetings, scientific advisory boards and clinical development discussions.

· Identify and qualify new clinical centers for Phase I and subsequent MRD-positive AML studies.

· Provide medical and clinical leadership in the selection and oversight of CROs, central laboratories, data management vendors, SMOs and other clinical service providers.

· Review CRO deliverables, timelines, quality metrics and budgets and ensure appropriate sponsor oversight.

· Participate in FDA meetings including Type D, Type C, End-of-Phase meetings and other regulatory interactions.

· Support preparation of briefing documents, clinical information amendments and protocol amendments.

· Provide clinical input into regulatory strategies for Orphan Drug Designation, RMAT, Fast Track and other expedited development pathways where appropriate.

Corporate and Business Support

· Provide clinical and medical input for business development, licensing, fundraising and investor due diligence.

· Support the company's Hong Kong clinical development platform and future Chapter 18A listing preparation.

· Present clinical development progress, key risks and strategic recommendations to senior management and the Board.

Qualifications – Essential

· MD or equivalent medical degree.

· Formal training in hematology, oncology, hematopoietic stem cell transplantation or a closely related discipline.

· Significant experience in pharmaceutical or biotechnology clinical development.

· Hands-on experience with early-phase oncology clinical trials.

· Strong understanding of Phase I dose escalation, DLT assessment and RP2D selection.

· Familiarity with ICH GCP and U.S. FDA clinical development requirements.

· Demonstrated ability to communicate effectively with investigators, CROs and regulatory authorities.

· Professional fluency in English.

Qualifications – Highly Preferred

· Clinical experience in AML, leukemia or hematologic malignancies.

· Experience with CAR-T, CAR-NK, NK cell therapy, T-cell therapy, stem-cell-derived therapy, gene therapy or other advanced therapy products.

· Prior experience working on an FDA IND-regulated program and/or interacting with FDA CBER/OTP.

· Experience conducting multinational or multi-regional clinical trials.

· Experience with MRD-directed AML clinical development.

· Experience interacting with DSMBs, DMCs or independent safety committees.

· Experience with both U.S. and Greater China clinical development.

· Cantonese and/or Mandarin would be advantageous but are not mandatory.

Candidate Profile

We are particularly interested in candidates who combine strong medical judgment with the ability to execute. This is a hands-on leadership role in a growing biotechnology company rather than a purely advisory medical position.

The successful candidate should be comfortable working in an entrepreneurial environment, making evidence-based clinical decisions, interacting directly with investigators and taking ownership of programs from early clinical development through registration-directed studies.

What We Offer

· Senior leadership role in a clinical-stage biotechnology company.

· Opportunity to lead the global development of an FDA IND-stage, iPSC-derived cell therapy.

· Direct involvement in U.S., Hong Kong and Greater China clinical programs.

· Significant influence over global clinical strategy and future pipeline development.

· Competitive compensation package, including performance-based incentives and potential stock option participation.

Application

Interested candidates are invited to submit their curriculum vitae, a brief summary of relevant clinical development experience, and current and expected compensation.

Applications will be treated in strict confidence. Only shortlisted candidates will be contacted.

薪酬： $50,000.00至$70,000.00（每月）

福利：

• 有薪年假
• 產假
• 膳食補貼
• 醫療保險

Work Location: 親身到場