(Senior) Program Manager, Toxicology

Responsibilities

• Support and manage Toxicology BU clients’ IND (Investigational New Drug) programs and oversee drug development progress.
• Closely collaborate with the LTD International Sales teams, Commercial Market team, TOX COC, TOX SD teams, scientists, and staff at WuXi’s Suzhou, Nantong sites.
• Provide technical support during the business development phase, including 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.
• Track relevant scientific advances by reviewing literature and sharing updates with the team and business units.

Qualifications

• 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.
• 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.