Portfolio Project Management Associate Director/Director

Job Summary

This role is responsible for end‑to‑end portfolio‑project management for Hanlin’s pipeline assets across all pre‑ and post‑approval development stages. The PPM will orchestrate shared‑resource deployment, drive cross‑functional alignment, monitor overall development timelines, and maximize portfolio value. The role covers full project lifecycle: initiation, planning, execution, monitoring and closure, and will lead delivery of IND, clinical trial and marketing authorization submissions. This position also owns pipeline reporting and supports external‑facing business activities.

Key Responsibilities

1. Own full‑lifecycle project management for Hanlin’s in‑development assets. Coordinate shared resources, facilitate cross‑department communication and collaboration, track development milestones, and maximize overall project and portfolio benefits.
2. Partner closely with IC, GPD, RA, CMC, AGQ and IP functions to align cross‑functional deliverables throughout project initiation, planning, execution, monitoring and closure phases. Drive progress toward Investigational New Drug (IND) applications, clinical trial applications, and marketing authorization submissions to achieve regulatory approvals.
3. Lead project initiation assessment, budget formulation, and periodic project reviews. Manage project scope, quality, timeline, risk and resources. Identify, assess and mitigate project risks, and organize cross‑functional problem‑solving for roadblocks during project delivery.
4. Organize project governance meetings, prepare and present project progress updates, and produce project documentation including project plans, requirement specifications, phase‑gate summaries, risk‑issue‑opportunity registers.
5. Oversee project change control, ensure project objectives remain aligned with corporate strategic priorities.
6. Maintain and distribute Hanlin pipeline progress updates to relevant stakeholders, including but not limited to annual report materials and monthly business review reports.
7. Support external‑facing teams including BD, IR, PR and Government Affairs. Activities include drafting and updating public R&D disclosure documents, consolidating pipeline‑related information for government collaborative projects and related inquiries.
8. Perform other duties as assigned by direct supervisor.

Requirements

1. Bachelor’s degree or above in Biology, Biotechnology/Bioengineering, Pharmaceutical Engineering, Pharmacology, Medicine or other relevant disciplines.
2. Minimum 5‑year working experience within biopharmaceutical industry, covering one or more areas such as project management, clinical operation, clinical medicine, biologic R&D, quality analysis, manufacturing or regulatory affairs. Prior portfolio‑project management experience for biologic/macromolecule drugs is strongly preferred.
3. Sound knowledge of pharmaceutical R&D‑related laws, regulations and guidelines, including GCP, GLP and ICH guidelines.
4. Proficient in written and spoken English and Chinese. Strong cross‑functional communication, coordination and team‑working skills. Advanced skills in Excel, PowerPoint, Microsoft Project and other office tools.
5. Self‑driven, efficient and flexible working style; result‑oriented. Able to operate under limited supervision within a fast‑changing environment, with proven stress tolerance. Strong learning agility and innovative thinking. PMP certification is preferred.