Senior Program Manager - Toxicology

Overview

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.

Education &

Experience : M.S. or Ph.D.

in Toxicology, Pharmacology, DMPK, or related biological areas with

6-plus years of working experience for M.S. and 4-plus years of

working experience for Ph.D. in pharmaceutical / biotech industries.

Extensive experience with in vitro or in vivo

studies in drug discovery and development required; background in

Toxicology and / or DMPK strongly preferred.

Extensive project management experience in leading nonclinical

programs preferred.

Excellent English verbal

and written communication skills; fluency in Mandarin required.

Strong interpersonal and teamwork skills.

Highly independent with strong

accountability.

Ability to conduct research

and perform literature reviews.

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.

Strong prioritization and flexibility in

managing changing directions.

Team-oriented

mindset with flexibility to work across time zones.

Familiarity with and adherence to regulatory

guidelines consistent with company requirements.