TOX-毒理商务中心项目经理(J25414)

The Project Manager will primarily support and manage clients’ IND (Investigational New Drug) programs and oversee drug development progress in both the U.S. and China. He/She will work closely with project teams.

Key Responsibilities：

1. Work independently or under supervision in a highly motivated project management team and dynamic environment.

2. Provide technical support during the business development phase, including but not limited to: understanding IND submission requirements of the U.S., China, and EMA; evaluating clients’ development programs; and preparing project proposals and preliminary study designs based on compound characteristics, clinical indications, intended clinical trial plans, existing data, and target submission regions.

3. Lead and manage the nonclinical portion of IND-enabling programs: develop program execution plans (Gantt charts), monitor program progress across pharmacology, DMPK/ADME, toxicology, bioanalysis, and regulatory submission activities; host regular project meetings to review status, study results, issues, and resolutions; and coordinate with other divisions for extended IND programs when needed.

4. Provide continuous scientific and technical support during program execution, proactively identify potential issues, and propose constructive solutions.

5. Maintain timely communication with clients and key internal contributors across functions/business units via email, teleconferences, Zoom meetings, and/or site visits to ensure smooth program execution.

6. Track relevant scientific advances by reviewing literature and share updates with the team and business units.

1. MS degree in Toxicology, Pharmacology, DMPK, or related fields.

2. At least 2 year of experience after a Master’s or Bachelor’s degree.

3. Experience with in vitro or in vivo studies in drug discovery and development required; background in Toxicology and/or DMPK strongly preferred.

4. Project management experience in leading nonclinical programs preferred.

5. Excellent English verbal and written communication skills; fluency in Mandarin required.

6. Strong interpersonal and teamwork skills.

7. Highly independent with strong accountability.

8. Ability to conduct research and perform literature reviews.

9. Knowledge / Skills / Abilities:

-Strong oral and written communication skills.

-Proficiency in MS Word, Excel, Outlook, PowerPoint, and other relevant software.

-Strong organizational skills, detail-oriented, and adaptable to changes.

-Ability to manage multiple projects under tight deadlines.