Job Description

Position Objectives:

• Drives, or contributes to, strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues.
• Joins multi-disciplinary, multi-regional, matrix teams as they address, and take decision in, highly complex circumstances.
• has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions.
• Apply clinical decision making to clinical development issues.
• interacts with and influences Neuroscience Therapeutic Area Unit and project or franchise leadership decision-making by contributing to strategic direction.

Success or failure directly translates to the ability of R&D to meet its corporate goals and for Takeda to have future commercial products

Key Accountabilities:

• Represents Clinical Science on Study Execution and Clinical Teams.
• Supports the Clinical Subteam to ensure that the clinical team activities are aligned with the global strategy.
• Contributes to Global Project and Clinical Subteam strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution.
• Recommends scope, complexity and size, and influences the budget of aspects of a study or program.
• Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications 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.
• Ensures that at all times the scientific rigor and integrity of clinical trials are maintained, and that the resulting data are of high quality to allow data-driven decision-making. In this role works with, and leads, other functional representatives to ensure optimal data quality.
• Ongoing work output will involve 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. Recommends high impact global decisions.

Synopsis / Protocol Development, Study Execution, & Study Interpretation:

• Oversees or contributes to Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical science personnel involved in these activities and contributes to the successful design and interpretation of clinical studies.
• Interprets data from an overall scientific standpoint as well as within the context of the clinical significance to individual patients.
• May present study conclusions to Management and determine how individual study results impact the overall compound strategy.

Data Monitoring:

• Responsible for clinical data monitoring activities, assessing issues related to protocol conduct, data quality and integrity, and participant well-being.
• Assesses overall safety information for studies and compound in conjunction with the study medical director and Pharmacovigilance.
• May oversee other clinical scientists with respect to assessment of these issues.
• Informs final decisions regarding study conduct related to scientific integrity.

External Interactions:

• Contributes to or leads interactions with study investigators, key opinion leaders relevant to assigned studies, compounds and therapeutic area.
• Contributes to developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing or summary documents), materials used for meeting presentations, and formal responses to communications received from the regulatory authorities, IRBs/ECs, or opinion leaders.
• Leads or contributes to incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.

Due Diligence, Business Development and Alliance Projects:

• Consulted for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
• Contributes to the development of clinical development plans and studies for potential alliances and or in-licensing opportunities and represents clinical science on internal assessment teams.
• For ongoing alliance projects, may interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner.

Leadership, Task Force Participation, Upper Management Accountability:

• Interacts with development functions, e.g. Data Science or Clinical Operations, and Drug Discovery Unit and other preclinical functions based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds.
• Represents clinical science and contributes to or leads internal task forces and Therapeutic Area internal teams as well as global cross-functional teams as appropriate.

Education, Experience, Knowledge and Skills:

Education and experience:

• Advanced life science degree or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Alternatively bachelor's degree and at least 5 years experience.

Skills:

• Superior communication, strategic, interpersonal and negotiating skills
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams
• Diplomacy and positive influencing abilities

Knowledge:

• Neurology therapeutic area knowledge desired
• Regional/global Regulatory requirements
• GCP/ICH

Travel Requirements:

Ability to drive to or fly to various meetings, Takeda R&D hubs. client sites, including overnight trips. Some international travel may be required.

Requires approximately -10 - 20% travel.

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:
USA - MA - Cambridge

U.S. Base Salary Range:
$177,000.00 - $278,080.00

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.

Locations
USA - MA - Cambridge

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.