Senior Program Manager - Toxicology

Project Manager

WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with worldwide operations. As an innovation-driven and customer-focused platform, WuXi AppTec provides a broad and integrated portfolio of services to help global customers and partners shorten the discovery and development timeline and reduce the cost of drug and medical device R&D through efficient and cost-effective solutions.

Within our Testing Division, we provide world-class, globally integrated testing solutions to support drug development. We are committed to helping scientists transform innovative ideas into leading healthcare products, accelerating the journey from the laboratory to the clinic, and ultimately improving human health.

We are currently seeking a Project Manager to join the Toxicology Commercial Operations Center (TOX COC) Project Management team, based in US as a remote employee. This role requires close collaboration with both U.S. and China BD teams, as well as the operations teams in China. Due to the need for deep engagement, fluency in both Chinese and English is required.

Responsibilities

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 TOX COC Project Management team and scientists at WuXi's Suzhou, Nantong, and other sites.

Key Responsibilities :

• Work independently with minimal supervision in a highly motivated project management team and dynamic environment.
• 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.
• 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.
• Provide continuous scientific and technical support during program execution, proactively identify potential issues, and propose constructive solutions.
• 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.
• Track relevant scientific advances by reviewing literature and sharing updates with the team and business units.

Qualifications

Education & Experience :

Knowledge / Skills / Abilities :