药物研发总监

Akeso Biopharma; New York (NY); On-site; USD 120,000 - 180,000; Full time

Job summary

Akeso Biopharma is seeking a PhD-level preclinical R&D project leader to manage the full lifecycle of innovative drug programs. You will design studies, plan milestones, manage budgets, and drive cross-functional collaboration across biology, pharmacology, and analytics teams to meet development goals.

The role requires deep scientific background, excellent problem-solving, and capability to draft initiation reports and regulatory documents.

Qualifications

• Ph.D. required in biology/related discipline.
• 3–5+ years in preclinical drug R&D.
• 2+ years leading projects or managing teams.
• Familiarity with biologics or gene-therapy preclinical process preferred.
• Ability to draft technical documents including reports and regulatory submissions.

Responsibilities

• Manage full preclinical R&D project lifecycle from initiation to IND-related activities.
• Develop annual, quarterly, and monthly R&D plans and milestones; oversee progress and risk.
• Lead resolution of core technical challenges; optimize protocols and data quality.
• Coordinate organization, analysis, and retrospective review of R&D data; ensure data traceability.
• Support R&D pipeline planning, new project selection, and feasibility analyses.

Skills

Project management

Cross-functional collaboration

Data analysis

TechnicalProblem solving

Documentation drafting

Education

Ph.D. in Biology, Pharmacology, Biotechnology, or related field

Job description

Company introduction was not provided in the original job description.

This role is responsible for end-to-end project management and technical problem-solving across the full preclinical R&D process for innovative drugs, covering target identification, project initiation evaluation, study design, and experiment execution, as well as pipeline planning and industry research. The role ensures that projects achieve established milestones on schedule and supports the delivery of the company's R&D strategy.

Independently manage the full preclinical R&D project lifecycle for innovative drugs, covering target identification, project initiation justification, study design, and experiment execution. Develop annual, quarterly, and monthly R&D plans, break down work packages and milestones, and oversee project progress, R&D quality, and risk control throughout, ensuring projects achieve established milestones on schedule.

Lead the resolution of core technical challenges in R&D; review and optimize experimental protocols; and tackle key technical bottlenecks in the development process. Coordinate the organization, analysis, and retrospective review of R&D data; standardize laboratory records and data traceability; ensure the scientific rigor, completeness, and reliability of R&D outcomes; and continuously improve the R&D technical system and experimental workflows.

Track frontier technologies in drug R&D, target dynamics, industry policies, and regulatory review trends both domestically and internationally. Conduct competitive intelligence research and patent searches and analyses. Support the department in R&D pipeline planning, new project selection, and project initiation evaluation, and deliver feasibility analysis reports to support the execution of the company's R&D strategy.

Ph.D. in Biology, Pharmacology, Biotechnology, or a related discipline.

3–5+ years of experience in preclinical drug R&D; 2+ years of experience leading projects or managing teams. Familiarity with the full R&D process for large-molecule (biologics) or gene-therapy innovative drugs is required. Candidates with end-to-end experience from project initiation through IND filing, or with CRO/pharmaceutical R&D project management experience, are preferred.

Solid command of R&D technologies and experimental methods in the relevant field; in-depth knowledge of drug development processes; strong capabilities in data analysis, technical review, and problem-solving, with the ability to independently resolve key technical issues in R&D; proficiency in searching Chinese and English literature and patents; and the ability to independently draft technical documents, including project initiation reports, regulatory submissions, and project summaries.

Excellent project coordination, schedule management, and risk anticipation skills, with clear logical thinking and strong goal orientation. Strong cross-functional communication, internal/external collaboration, and resource integration skills to efficiently drive multi-party collaboration. Solid team management, coordination, and stress-resilience capabilities, with the ability to manage multiple R&D projects in parallel.

Meticulous, highly responsible, and firmly committed to R&D compliance standards; possessing sound professional ethics, strong teamwork, and innovative thinking; and aligned with the quality management and compliance system requirements of pharmaceutical R&D.

Preferred skills are not listed separately in the original job description; relevant preferences are covered under the Experience section above.

Compensation and benefits information was not provided in the original job description.

No equal employment opportunity or diversity and inclusion statement was provided in the original job description.