Takeda
Associate Director, Clinical Operations Program Lead (COPL)
Takeda, Boston, Massachusetts, us, 02298
Associate Director, Clinical Operations Program Lead (COPL)
Massachusetts - Virtual
Compensation U.S. Base Salary Range: $153,600.00 - $241,340.00 per year. This range is provided by Takeda and actual pay will be based on skills and experience. Benefits and incentives may apply.
Overview
Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and other vendors.
Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) responsible for the CDP development and execution.
Provide program-level sponsor’s operational oversight of strategic partners and vendors to ensure timely, high-quality clinical study execution within budget.
Accountabilities
Translate the CDP into an optimal operational strategy and plan for the GPT; assess operational scenarios for optimal CDP execution; align with the Global Program Leader and Global Clinical Lead.
Develop and lead the clinical program operational strategy in collaboration with Clinical Operations Managers (COMs), strategic partners, CROs, and other vendors.
Serve as the escalation point for COMs on unresolved issues at the study level; oversee performance of activities by strategic partners, CROs, and vendors.
Plan budgets and manage external spend related to clinical program execution; work with COMs, Global Program Manager (GPM), and Finance to monitor budgets, enrollment, and gating.
Participate in strategic cross-functional initiatives for process and business improvements; communicate program status to senior management to enable timely decision-making.
May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
Provide expert clinical operations input into clinical documents and regulatory meeting preparations; lead or participate in inspection readiness activities and regulatory inspections.
Lead or participate in cross-functional strategic initiatives and process improvement; seek ways to improve efficiency in clinical development.
Demonstrate Takeda leadership behaviors and model Takeda values.
Education, Experience, Knowledge and Skills Education:
Bachelor’s degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
Experience:
10+ years in pharmaceutical industry and/or CROs, including 7+ years in clinical study/project management. Experience in early phase (Phase 1) or later global programs, with exposure to more than one therapeutic area preferred. Knowledge of global regulatory and compliance requirements (e.g., US CFR, EU CTD, ICH GCP) and local country requirements.
Skills:
Program management excellence, including scenario assessment, risk assessment, and contingency planning
Matrix leadership and strong communication abilities
Ability to influence without formal authority
Teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
Entrepreneurial and innovative mindset; comfortable with change and ambiguity
Culture of continual improvement and knowledge sharing
Fluent business English (oral and written)
Travel Requirements
Requires up to 10% travel, including overnight and international travel to Takeda sites, strategic partners, and therapeutic area travel as required.
Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. Takeda is committed to equitable pay and transparent pay practices.
EEO Statement Takeda is proud of its commitment 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, 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 Massachusetts - Virtual
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.
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Compensation U.S. Base Salary Range: $153,600.00 - $241,340.00 per year. This range is provided by Takeda and actual pay will be based on skills and experience. Benefits and incentives may apply.
Overview
Develop and lead the program-level operational strategy and planning on assigned programs in close collaboration with strategic partners and other vendors.
Represent Clinical Operations at the Global Program Team (GPT) and partner with Global Clinical Lead to lead the Clinical Sub Team (CST) responsible for the CDP development and execution.
Provide program-level sponsor’s operational oversight of strategic partners and vendors to ensure timely, high-quality clinical study execution within budget.
Accountabilities
Translate the CDP into an optimal operational strategy and plan for the GPT; assess operational scenarios for optimal CDP execution; align with the Global Program Leader and Global Clinical Lead.
Develop and lead the clinical program operational strategy in collaboration with Clinical Operations Managers (COMs), strategic partners, CROs, and other vendors.
Serve as the escalation point for COMs on unresolved issues at the study level; oversee performance of activities by strategic partners, CROs, and vendors.
Plan budgets and manage external spend related to clinical program execution; work with COMs, Global Program Manager (GPM), and Finance to monitor budgets, enrollment, and gating.
Participate in strategic cross-functional initiatives for process and business improvements; communicate program status to senior management to enable timely decision-making.
May participate in Business Development/in-licensing/alliances evaluations by providing operational due diligence.
Provide expert clinical operations input into clinical documents and regulatory meeting preparations; lead or participate in inspection readiness activities and regulatory inspections.
Lead or participate in cross-functional strategic initiatives and process improvement; seek ways to improve efficiency in clinical development.
Demonstrate Takeda leadership behaviors and model Takeda values.
Education, Experience, Knowledge and Skills Education:
Bachelor’s degree or international equivalent required; Life Sciences preferred. Advanced degree highly desirable.
Experience:
10+ years in pharmaceutical industry and/or CROs, including 7+ years in clinical study/project management. Experience in early phase (Phase 1) or later global programs, with exposure to more than one therapeutic area preferred. Knowledge of global regulatory and compliance requirements (e.g., US CFR, EU CTD, ICH GCP) and local country requirements.
Skills:
Program management excellence, including scenario assessment, risk assessment, and contingency planning
Matrix leadership and strong communication abilities
Ability to influence without formal authority
Teamwork, organizational, interpersonal, conflict resolution and problem-solving skills
Entrepreneurial and innovative mindset; comfortable with change and ambiguity
Culture of continual improvement and knowledge sharing
Fluent business English (oral and written)
Travel Requirements
Requires up to 10% travel, including overnight and international travel to Takeda sites, strategic partners, and therapeutic area travel as required.
Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. Takeda is committed to equitable pay and transparent pay practices.
EEO Statement Takeda is proud of its commitment 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, 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 Massachusetts - Virtual
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.
#J-18808-Ljbffr