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MD or Clinical PhD in Obstetrics & Gynecology

Lead end-to-end clinical studies (GCP/IRB compliance)

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Director, Clinical & Medical Affairs — Obstetrics & Gynecology

SHANYA INTERNATIONAL LIMITED
HK $25K-45K/Month, Salary negotiable, High commission with base salary
No degree required
No experience limit
HK work permit required
9.0 hrs/day, 5 days/wk, Office work,Require to Travel,Hybrid / WFH

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Job Description

We are a HKU-derived biotech (incubated via HKU and HK Science Park) building integrated female-health solutions based on menstrual-blood biomarkers. We're mission-driven and looking for a medically rigorous leader to drive clinical strategy and medical translation.

Key responsibilities

Clinical research & regulatory

  • Lead design, implementation and analysis of clinical studies (GCP/IRB compliance).

  • Manage clinical partnerships with tertiary hospitals, departments and key opinion leaders.

  • Drive regulatory strategy and dossiers (NMPA, FDA, etc.); draft/review medical & regulatory documents.

Clinical value & product translation

  • Identify unmet clinical needs and evaluate clinical potential of new biomarkers/technologies.

  • Provide medical input for R&D prioritization and product roadmap; translate clinical needs into product requirements and validation plans.

Medical knowledge & algorithm standards

  • Develop clinical decision logic, annotation standards and QC for algorithm development in O&G/reproductive medicine.

  • Collaborate closely with engineering/data teams during model training and validation to ensure clinical accuracy and applicability.

Medical communication & leadership

  • Build and maintain advisory network; produce medical content (data interpretation, conference presentations).

  • Represent the company at academic meetings and lead scientific engagement.

Requirements (essential)

  • MD or Clinical PhD in Obstetrics & Gynecology, Reproductive Medicine, Gynecologic Oncology, or closely related field.

  • 3–8 years clinical or research experience in relevant areas.

  • Eligible to live and work in Hong Kong (permanent resident or valid work visa/permit).

  • Able to independently run clinical studies end-to-end (protocol, ethics, execution, analysis); strong knowledge of GCP and IRB processes.

  • Experience with diagnostic evaluation (ROC/AUC, sensitivity/specificity) and common statistics; proficient with R, Python or SPSS.

  • Track record of SCI publications and strong cross-functional communication/project management skills.

Preferred (plus)

  • Experience in medtech/IVD/POCT, digital health, FemTech or biomarker clinical development and regulatory submissions.

  • Experience in product commercialization, startups or incubations.

  • MBA or training in medical/health informatics, bioinformatics is a plus.

  • Established expert network in O&G/reproductive medicine and first/corresponding author publications; conference speaking experience.

  • Interest or hands-on experience applying AI in healthcare.

What we offer

  • Competitive salary + employer MPF and equity for early core team members.

  • Opportunity to lead end-to-end development of a novel female-health product and shape clinical and regulatory strategy.

  • Paid leave (negotiable) and full travel expense reimbursement.


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