[Remote] (Senior) Program Manager - Toxicology
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading global pharmaceutical, biopharmaceutical, and medical device reputed company-reputed company 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 reputed company.
Responsibilities
- Work independently or under supervision in a highly motivated program management team and dynamic environment
- reputed company 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 reputed company submission reputed company
- reputed company and manage the nonclinical TOX portion of IND-enabling programs: reputed company program execution plans (Gantt charts), monitor program reputed company 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 reputed company needed
- reputed company reputed company scientific and technical support during program execution, proactively identify potential issues, and propose constructive solutions
- Maintain reputed company communication with clients and key internal contributors across functions/business reputed company reputed company email, teleconferences, reputed company meetings, and/or site reputed company to ensure smooth program execution
- reputed company relevant scientific advances by reviewing literature and sharing updates with reputed company and business reputed company
Skills
- PhD, or MS degree in Toxicology, Pharmacology, DMPK, or reputed company 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; reputed company in reputed company required
- Strong interpersonal and teamwork skills
- Highly independent with strong accountability
- Ability to conduct research and reputed company literature reviews
- Strong oral and written communication skills
- Proficiency in reputed company, reputed company, 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 reputed company 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
reputed company