Skip to main content

求人検索

プロフィールを使用して検索

Toxicologist – Nonclinical Safety Assessment, Principal Scientist

応募後で応募 求人ID R0057650 掲載日 01/24/2022 Location:Boston, Massachusetts

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Toxicologist – Nonclinical Safety Assessment, Principal Scientist, in our Cambridge, Massachusetts office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

As a Toxicologist – Nonclinical Safety Assessment, Principal Scientist, working on the Drug Safety Research and Evaluation (DSRE) team, you will be empowered to 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.  A typical day will include:

POSITION OBJECTIVES:

This position will support programs across Takeda’s 4 therapeutic areas: oncology, gastroenterology, neuroscience and rare diseases. The programs will involve a broad range of modalities that include small molecules, protein therapeutics, oligonucleotides, and cell and gene therapies. As a member of multi-disciplinary project teams, the individual will engage with experts from other functions (e.g., Regulatory Affairs, Manufacturing, Pharmacovigilance, and Clinical Research) to develop project plans and go/no-go criteria, and then develop safety testing strategies that support the project plans and decision-making. The individual must be scientifically independent and able to articulate implications and risks from safety findings to a broad audience, as well as propose mitigation strategies when appropriate. The ideal candidate will also have experience in immunology-related targets, or cell- or gene-based therapies. Pharmaceutical experience working on development project teams and interacting with health authorities is required.

POSITION ACCOUNTABILITIES:

  • Serve as the DSRE team representative on development programs in GI, neuroscience, oncology and rare diseases areas, across a range of modality types
  • If appropriately experienced, provide guidance and recommendations to others in DSRE on safety assessments for immunology-related targets, or cell- or gene-based therapies.
  • Serve as study director on internal exploratory studies, and scientifically oversee the design, reporting and interpretation of exploratory and GLP-compliant outsourced safety studies
  • 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
  • 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
  • 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

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

  • PhD in toxicology or related discipline, with 6+ years of pharmaceutical experience working on development project teams; or MS with 12+ years of pharmaceutical experience
  • Experience authoring regulatory safety assessments documents (IND, CTA, NDA, MAA, etc.)
  • Experience in design, reporting, and interpreting safety studies, and experience in the conducting GLP studies
  • Good collaboration and communication skills working in team environments and in matrixed-management settings
  • Board certification is desired (DABT or DAVBT)

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

This job posting excludes CO applicants

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement
  • Company match of charitable contributions
  • Health & Wellness programs including onsite flu shots and health screenings
  • Generous time off for vacation and the option to purchase additional vacation days
  • Community Outreach Programs

Empowering Our People to Shine

Learn more at takedajobs.com

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.

#LI-NS1

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
応募後で応募