Takeda
Senior Director, Business Process Owner, Medical Safety Sciences
Takeda, Boston, Massachusetts, us, 02298
Overview
Senior Director, Business Process Owner, Medical Safety Sciences. Base pay range: $208,200.00/yr - $327,140.00/yr. Location: Boston, MA and Zurich, Switzerland. U.S. base salary range and compensation details are provided in the Employer’s compensation summary. Responsibilities
Primarily responsible for the design, procedural documentation, implementation, management, and oversight of the Reference Safety Information (RSI) end-to-end process in QMS and other business guidance documents. As needed, the scope may expand to other end-to-end processes or projects owned by Medical Safety Sciences, PSPV (includes Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports). Develop the roadmap and implementation plan for bringing key support functions including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports, including communications. Oversee implementation of related processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs). Technical/Functional (Line) Expertise
Deep knowledge and subject matter expertise on the existing end-to-end process(es). Comprehensive understanding of ICH, MHRA, and other regulatory intelligence. Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment. Leadership
Provides clear direction on requirements to meet the expectations of all business stakeholders. Capable of reconciling conflicting views into a cohesive path forward. Demonstrated ability to work across functions, regions, and cultures. Enterprise-level leadership with the ability to inspire, motivate, and drive results. Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing. Proven skills as an effective team player who can engender credibility and confidence within and outside the company. Ability to distill complex issues and ideas down to simple, comprehensible terms. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Decision-making and Autonomy
Cross-functional collaboration to synthesize diverse inputs from multiple constituents and stakeholders to drive innovative solutions. Accountable for decision-making for the designated function. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution. Accountable for designing and implementing vision and strategy for the designated scope. Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace. Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions. Innovation
Comfortable challenging the status quo and bringing forward innovative solutions. Identify and manage interdependence across processes to improve the process and achieve business benefit. Complexity
Ability to work in a global ecosystem with a high degree of complexity. Breadth of knowledge required across therapeutic areas, indications, and/or modalities. Skills and Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, with a focus on clinical drug development including but not limited to Pharmacovigilance. Experience in people leadership, managing matrix teams, and coordinating collaboration with cross-functional teams. Strong strategic thinking, planning, execution, and communication skills. Global/international experience required, including the ability to collaborate with colleagues and staff in other locations. Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Compensation and Benefits
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: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, experience, skills, education, licenses, and location. Base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, health benefits, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other protected characteristics, in accordance with applicable laws. Locations
Boston, MA; Zurich, Switzerland 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. Any employer who violates this law may face penalties under applicable law.
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Senior Director, Business Process Owner, Medical Safety Sciences. Base pay range: $208,200.00/yr - $327,140.00/yr. Location: Boston, MA and Zurich, Switzerland. U.S. base salary range and compensation details are provided in the Employer’s compensation summary. Responsibilities
Primarily responsible for the design, procedural documentation, implementation, management, and oversight of the Reference Safety Information (RSI) end-to-end process in QMS and other business guidance documents. As needed, the scope may expand to other end-to-end processes or projects owned by Medical Safety Sciences, PSPV (includes Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports). Develop the roadmap and implementation plan for bringing key support functions including Risk Management & Benefit Risk, Signal Management, Medical Review, and Aggregate Reports, including communications. Oversee implementation of related processes and technologies in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs). Technical/Functional (Line) Expertise
Deep knowledge and subject matter expertise on the existing end-to-end process(es). Comprehensive understanding of ICH, MHRA, and other regulatory intelligence. Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environment. Leadership
Provides clear direction on requirements to meet the expectations of all business stakeholders. Capable of reconciling conflicting views into a cohesive path forward. Demonstrated ability to work across functions, regions, and cultures. Enterprise-level leadership with the ability to inspire, motivate, and drive results. Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing. Proven skills as an effective team player who can engender credibility and confidence within and outside the company. Ability to distill complex issues and ideas down to simple, comprehensible terms. Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Decision-making and Autonomy
Cross-functional collaboration to synthesize diverse inputs from multiple constituents and stakeholders to drive innovative solutions. Accountable for decision-making for the designated function. Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution. Accountable for designing and implementing vision and strategy for the designated scope. Interaction
Effectively navigates the changing external and internal environment and leads others through change by creating an inspiring and engaging workplace. Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions. Innovation
Comfortable challenging the status quo and bringing forward innovative solutions. Identify and manage interdependence across processes to improve the process and achieve business benefit. Complexity
Ability to work in a global ecosystem with a high degree of complexity. Breadth of knowledge required across therapeutic areas, indications, and/or modalities. Skills and Qualifications
Bachelor’s Degree or international equivalent required; Life Sciences preferred. 15+ years’ experience in the pharmaceutical industry and/or clinical research organization, with a focus on clinical drug development including but not limited to Pharmacovigilance. Experience in people leadership, managing matrix teams, and coordinating collaboration with cross-functional teams. Strong strategic thinking, planning, execution, and communication skills. Global/international experience required, including the ability to collaborate with colleagues and staff in other locations. Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development. Health care business acumen with a comprehensive understanding of the pharmaceutical industry. Compensation and Benefits
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: $208,200.00 - $327,140.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including qualifications, experience, skills, education, licenses, and location. Base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, health benefits, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid time off, holidays, and well-being benefits. EEO Statement
Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity or expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, veteran status, or other protected characteristics, in accordance with applicable laws. Locations
Boston, MA; Zurich, Switzerland 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. Any employer who violates this law may face penalties under applicable law.
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