(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 Program Manager/Sr. Program Manager (depending on experience) to join the Toxicology Strategic Programs team as a U.S.-based remote employee.

This role requires close collaboration with both the U.S. and Europe BD teams, as well as the TOX Commercial Operations Center (TOX COC) in China. The primary working language is English, but due to the need for deep engagement and communication, fluency in Mandarin is a requirement. Preferred location is the U.S. East Coast, particularly the Boston area.

Responsibilities

The Program Manager will primarily support and manage Toxicology BU clients’ IND (Investigational New Drug) programs and oversee drug development progress. He/She will work closely with the LTD International Sales teams, Commercial Market team, TOX COC, TOX SD teams, scientists, and staff at WuXi’s Suzhou, Nantong sites.

• Work independently or under supervision in a highly motivated program 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 program 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 TOX portion of IND-enabling programs: develop program execution plans (Gantt charts), monitor program progress across  toxicology, preclinical 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:

• PhD, or MS degree in Toxicology, Pharmacology, DMPK, or related fields.
• 2 - 3 years of post-PhD experience, or 5+ years of experience after a Master’s degree.
• Experience with in vitro or in vivo studies in drug discovery and development required; background in Toxicology and/or DMPK strongly preferred.
• Program 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 programs 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.

The expected annual base salary for this position is $110,000 to $130,000.