[Hiring] Associate Director, GCP Excellence in Clinical Trials @USA - 3316 Takeda Development Center Americas, Inc.
Mar 29, 2025 - USA - 3316 Takeda Development Center Americas, Inc. is hiring a remote Associate Director, GCP Excellence in Clinical Trials. 💸 Salary: base salary range: $149,100 - $234,300. 📍Location: USA.
Role Description
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as an Associate Director, GCP Excellence in Clinical Trials based remotely reporting to the Director, GCP Excellence in Clinical Trials. 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 work towards their potential through life-changing work.
- Implement and drive management of cross-functional study execution teams’ GCP inspection readiness and inspection preparation strategies.
- Partner with R&D Quality to serve the Clinical Sub-Team (CST)/Study Execution Team (SET) for end-to-end clinical trial delivery compliance.
- Increase compliance effectiveness by driving implementation of global initiatives.
- Champion change and provide direct operational excellence strategies for clinical trial delivery projects and initiatives.
Accountabilities
- Lead the development and implementation of GCP Excellence in Clinical Trials strategies.
- Partner with R&D Quality and GCP Compliance Management to develop GCP inspection strategy.
- Drive strategies to facilitate and prepare Takeda Study Execution Team for GxP audits and inspections.
- Collaborate with study execution team leadership on adherence to clinical trial delivery procedures.
- Proactively identify and lead assessments for process/therapeutic area/project risks.
- Develop, lead and oversee strategies for GCP quality and inspection plans.
- Oversee global and program aligned GCP Excellence in Clinical Trials support.
- Ensure effective approach to actively lead Strategy Team Meetings and Core Team Meetings.
- Collaborate across GCP Excellence in Clinical Trials and with GCP Compliance Management.
- Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
- Monitor and provide visibility into inspection readiness and TMF health for global studies.
- Identify and implement areas for process optimization and delivery tools.
- Drive strategy and implementation of risk-based TMF oversight strategies.
- Serve as subject matter expert for Inspection Readiness and TMF.
- Contributes to and may lead defined GCP Excellence in Clinical Trials initiatives.
- Responsible for training, coaching and mentoring supervised employees.
Qualifications
- Bachelor’s Degree in Life Sciences or international equivalent preferred.
- 8 or more years' experience in the pharmaceutical industry and/or clinical research organization.
- 6+ years in compliance or clinical study management or equivalent.
- Experience in leading projects and coordinating collaboration with cross-functional teams.
- Strong strategic thinking, planning, execution, and communication skills.
- Global/international experience required.
- Operational experience in clinical development with significant direct exposure to implementation of novel approaches.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Benefits
- Base Salary Range: $149,100.00 - $234,300.00.
- U.S. based employees may be eligible for short-term and/or long-term incentives.
- Medical, dental, vision insurance.
- 401(k) plan and company match.
- Short-term and long-term disability coverage.
- Basic life insurance.
- Tuition reimbursement program.
- Paid volunteer time off.
- Company holidays and well-being benefits.
- Up to 80 hours of sick time per calendar year.
- 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.
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
base salary range: $149,100 - $234,300
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Mar 29, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
