The opportunity
You will lead execution of the biopharma’s first oncology asset, an innovative biologic entering IND-stage development. You will be the central coordinator across clinical development, CROs, CDMOs, regulatory consultants, investigators and management. As the portfolio grows, you will take on additional assets.
What you’ll do
- Lead clinical operations and project execution from IND preparation through Phase I/II
- Manage CRO selection, study start-up, site activation, enrolment, trial conduct and data cleaning
- Coordinate protocol development with management, investigators, medical advisors, biostatisticians and regulatory consultants
- Drive cross-functional planning across clinical, regulatory, CMC, biomarker, safety and clinical supply
- Act as the primary interface with CDMOs, aligning manufacturing and clinical-supply timelines
- Track critical-path risks and vendor performance, and resolve issues proactively
- Engage KOLs and investigators, and give management concise, decision-oriented updates
- Help build scalable clinical and operational processes as the pipeline expands
What you bring
- 10-15+ years in clinical development or clinical operations, ideally at Director or Senior Director level
- Experienced in owning the development plan, challenge partners, anticipate problems and keep the programme moving.
- Strong Phase I/II oncology experience, preferably including first-in-human studies
- IND/CTA preparation and early clinical development experience
- A strong track record managing CROs and complex vendor relationships
- Biologics experience strongly preferred
- Biotech experience, ideally paired with earlier time in larger pharma
- China/APAC clinical development experience, with global exposure preferred
- Fluency in English is required for cross-functional communication, and professional proficiency in Mandarin is required for direct communication, technical discussions and coordination with China-based biotech partners and clinical development stakeholders.
- A hands-on, detail-oriented style and comfort being the single point of accountability in a lean team
AM
Reg. No. R1110770
BeathChapman Pte Ltd
Licence no. 16S8112
