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, primarily supporting and managing Toxicology BU clients’ IND programs while overseeing drug development progress.
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
- 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
- Background in Toxicology and/or DMPK strongly preferred
- Program management experience in leading nonclinical programs preferred
Benefits
- U.S.-based remote employee
- Preferred location is the U.S. East Coast, particularly the Boston area
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