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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on three therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Director, Toxicology Project Support within our Global Drug Safety Research & Evaluation (DSRE) organization, based in Cambridge, MA. As part of the Global Toxicology Team, work in interdisciplinary teams within and across Global Safety to provide safety support to early discovery and development teams as well as engage in core activities within the Toxicology group. You will report to Senior Director, Toxicology.

How you will contribute:

• As part of the Global Toxicology Team, work in interdisciplinary teams within and across Global Safety to provide safety support to early discovery and development teams as well as engage in core activities within the Toxicology group

• Work as part of a team of safety assessment scientists and more broadly DMPK, pathology, pharmacology, and medicinal chemistry experts to implement toxicology strategy to enable the selection and progression of optimized drug candidates

• Serve as the DSRE project team member on multi-discipline research and development teams, being responsible for design, reporting, and interpretation of regulatory nonclinical safety studies.

• Organizational leader with responsibilities and strategic influence across multiple functions and/or external collaborations.

• Interacts with other functional area experts in a project team environment to recommend the best course of action for a program given the nonclinical safety risks, and defend those recommendations to internal governance committees (PRC, PRF, Safety Board, etc.)

• Responsible for creating and communicating a clear vision and strategy for his/her area of primary responsibility, directed toward establishment and progression of an industry-leading research portfolio

• Provide pharmaceutical drug project teams with expert advice and direction to improve the quality of therapeutics selected for further development based on proactive risk assessment of target-, platform- and chemotype-related toxicities.

• Lead the development and implementation of the nonclinical safety strategy through development of clinical stage and post-marketing assets

• Responsible for effective management and utilization of resources to maximize the team’s impact on Takeda’s pipeline

• Proposes and implements strategies for compound development, finds and uses key opinion leaders, clinical investigators and SAB members to further development goals; makes significant “outward facing” scientific contributions

• Provides leadership and strategic support to other parts of the Takeda organization, and/or to external collaborators

• Succinctly and effectively summarizes the content and safety implications from nonclinical studies for regulatory submissions, including components for IBs and clinical protocols

• Interact with Health Authorities, in writing and verbally

• Represents Takeda in external venues, including scientific meetings and with potential partners

• Provide evaluation for in-licensing opportunities that clearly articulate risks and recommendations for mitigating risks

• Exhibits the highest standard of scientific integrity and functions as a role model for peers/subordinates to always make ethical decisions

Minimum Requirements/Qualifications:

• PhD in pharmacology or toxicology with at least 10 years of industry experience, a Master’s degree with a least 14 years industry experience, or BS with 16 years working as a research project member at a pharmaceutical company

• Expert knowledge and experience of toxicology support of Drug Discovery and Development Process from target identification through LCM. Recognized internally and externally as a scientific leader and expert

• Experience in design, reporting, and interpreting safety studies, and experience in the conducting GLP studies

• Exceptional project management skills and communication skills working in team environments and in matrixed-management settings

• Experience authoring regulatory safety assessments documents (IND, CTA, NDA, MAA, etc.)

• Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise

• Board certification is desired (DABT or DAVBT)

More About Us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “hybrid” by Takeda’s Hybrid and Remote Work policy. This position requires the candidate to come onsite to Cambridge location minimum 5x/month.

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:

$169,400.00 - $266,200.00

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