[Remote] (Senior) Program Manager, Toxicology

Note: The job is a remote job and is open to candidates in USA. WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with worldwide operations. They are currently seeking a Program Manager/Sr. Program Manager to join the Toxicology Strategic Programs team, focusing on managing Toxicology BU clients’ IND programs and overseeing drug development progress. This role involves collaboration with various teams and requires fluency in Mandarin.

Responsibilities

• 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

Skills

• 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
• 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 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
• Program management experience in leading nonclinical programs preferred

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