Clinical Scientist - Oncology

Takeda Pharmaceutical Company Limited; Boston (MA); On-site; USD 120,000 - 182,000; Full time

Job summary

Takeda is seeking a Clinical Scientist for our Cambridge/Boston area to lead regional clinical development activities and collaborate with global teams. The role focuses on developing regulatory strategies, protocols, and study design to support compounds through multiple regions.

You will contribute to safety monitoring, external interactions with regulatory authorities, and leadership of cross-functional teams across US/EU/Japan.

Qualifications

• Bachelor's degree with 6 years, Master's with 4 years, PharmD with 2 years, or PhD with 1 year of clinical research and/or clinical development experience in the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical academia.
• Superior communication, strategic, interpersonal and negotiating skills.
• Ability to express oneself clearly and concisely to external partners or within the team.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team.

Responsibilities

• Lead Clinical Development team participation and leadership for regional development.
• Represent Clinical Science on US/EU Development Teams and support Global Development Team alignment.
• Contribute to Development Strategy and Clinical Protocols across assigned sections.
• Participate in budgeting discussions for program scope, complexity, and size.
• Provide ongoing evaluation of development strategy ensuring regulatory alignment and contingencies.
• Interact with regulatory authorities and key opinion leaders to shape company positions and study designs.

Skills

Superior communication

Strategic thinking

Regulatory and clinical development

Team leadership

Problem solving

GCP/ICH knowledge

Education

Bachelor's degree with 6 years / Master's with 4 years / PharmD with 2 years / PhD with 1 year of clinical research and/or clinical development experience

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 Clinical Scientist in our Cambridge 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 deliverBetter Health and a Brighter Future to people around the world.

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

OBJECTIVES:

The Clinical Scientist represents, and may lead, clinical science on the regional (US or other region) clinical development of assigned Takeda pipeline compounds. Leads a multi-disciplinary, matrixed team ensuring that scientific issues are appropriately considered with respect to highly complex data findings. This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan that will result in the regulatory approval of the compound in multiple regions.

ACCOUNTABILITIES:

• Clinical Development team participation and leadership
• Represents Clinical Science on US/EU Development Teams and may serve as leader of this team. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy.
• Responsible deliverables producing the Development Strategy, with significant contributions to assign sections of the Clinical Development Plan and Clinical Protocols.
• Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program.
• Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them for those areas assigned.
• Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies and making recommendations that impact regional and global development such as "go/no go" decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.
• Responsible for the creation and securing governance approval of the Synopsis / Protocol Development, Study Execution, & Study Interpretation
• Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans) for assigned sections. Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings). Responsible for review of study data, interpretation of results and communication of study conclusions within the company for assigned sections.

Trial Medical Monitoring

• Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
• Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.

External Interactions

Successfully contributes to interactions with regulatory authorities / agencies and key opinion leaders relevant to assigned compound and participate in meetings with representatives of the regulatory organizations and the identification / contact / maintenance of strong Company relationships with key opinion leaders. Influences establishment of strategy for the compound, and the development of documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received by the Company. Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate.

Leadership, Task Force Participation, Upper Management Accountability

Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as Development scientific content matter expert for assigned compounds. May represent clinical science on internal task forces. May lead internal teams as appropriate.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

• Bachelor's degree and 6 years, master's degree and 4 years, PharmD degree and 2 years, or PhD and 1 year of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
• Superior communication, strategic, interpersonal and negotiating skills
• Ability to express oneself clearly and concisely to external partners or within the team.
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix team
• Diplomacy and positive influencing abilities
• Therapeutic area knowledge relevant to mechanism of action
• Regional/global Regulatory requirements
• GCP/ICH
• Emerging research in designated therapeutic area

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

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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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:

$116,000.00 - $182,270.00

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.