Senior Program Manager - Toxicology

Overview

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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.

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Responsibilities

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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.

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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.