(Senior) Program Manager - Toxicology

About the role

The Program Manager/Sr. Program Manager will support and manage Toxicology BU clients' IND programs and oversee drug development progress. They will collaborate with the U.S. and Europe BD teams, as well as the TOX Commercial Operations Center (TOX COC) in China. Fluency in Mandarin is required, with preference for a location on the U.S. East Coast, particularly the Boston area.

Responsibilities

• Understand IND submission requirements of the U.S., China, and EMA
• Evaluate clients' development programs
• Prepare program proposals and preliminary study designs based on compound characteristics, clinical indications, intended clinical trial plans, existing data, and target submission regions
• Develop program execution plans (Gantt charts)
• Maintain regular project meetings to review status, study results, issues, and resolutions
• Coordinate with other divisions for extended IND programs when needed
• Provide continuous scientific and technical support during program execution
• Identify potential issues and propose constructive solutions
• Track relevant scientific advances by reviewing literature and sharing updates with the team and business units

Requirements

• 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
• Background in Toxicology and/or DMPK 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

Qualifications

• 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

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

Pay

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