Job Description
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Job Description OBJECTIVE:
Nonclinical toxicology professional with pharma/CRO industry experience with a strong background in laboratory in vivo research and nonclinical toxicology study management.
Manage regulated (GLP) and non-GLP nonclinical discovery and development studies at Contract Research Organizations (CROs).
Facilitate facets of toxicology studies including study monitoring, team management, account management, and coordinating deliverables for regulatory (IND) submission timelines.
ACCOUNTABILITIES:
Lead outsourced toxicology study forecasting, planning, and protocol development activities.
Review study-related documents (scope of work, protocols, amendments, and reports) for completeness, accuracy, and consistency with relevant regulatory guidance documents/regulations and safety assessment policy.
Schedule milestones of study activities as well as corresponding data or reports from internal and external laboratories.
Track reporting deliverables and upload or graph real-time data.
Import finalized documents (protocols, amendments, and reports) to the Takeda EDMS and SEND data to internal portal.
Coordinate study activities across multiple departments in Global Takeda (DSRE, Pharmaceutical Sciences, DMPK, and QA, etc.).
Ensure timely finalization of nonclinical study reports to support regulatory submissions.
Provide toxicology support for Occupational and Environmental Toxicology (e.g., contribute to management of outsourcing) and Marketed Products portfolio (e.g., contribute to annual reporting documents).
Conduct comprehensive reviews of published literature and available public domain information for novel targets including tissue expression data for human and nonclinical species, relationship to naturally occurring disease, genetically modified animal models, and competitive intelligence to assist in authoring of target safety reviews.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Candidate should be motivated and proactive with a strong sense of responsibility to work with minimal supervision to achieve objectives in a timely manner.
Possess knowledge of FDA Good Laboratory Practice (GLP) Regulations as set forth in 21 CFR Part 58, OECD, and ICH guidelines.
Practice principles of good documentation.
Experience with the design and conduct of regulated nonclinical studies.
Strong interpersonal and organizational skills.
Experience in reviewing/auditing toxicology study data and reports.
Possesses excellent communication skills for internal and external liaison roles.
Proficiency with Microsoft 365 Products (Word, Excel, PowerPoint, Teams, Project, SharePoint, and OneNote), Smartsheet, and other common electronic systems including data visualization tools.
PhD degree in a scientific discipline with 2+ years relevant experience, or MS with 8+ years relevant experience, or BS with 10+ years relevant experience, working at a pharmaceutical company and/or CRO.
PHYSICAL DEMANDS:
Routine demands of an office-based environment.
TRAVEL REQUIREMENTS:
Ability to travel domestically and internationally, 5-25%.
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Boston, MA
U.S. Base Salary Range:
$133,000.00 - $209,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.
Locations: Boston, MA
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Job Exempt: Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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Job Tags
Minimum wage, Holiday work, Full time, Contract work, Temporary work, Local area,