Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Director, Global Development Special Initiatives based remotely reporting to the Head, Clinical Site Start Up and Engagement.
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. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future
to people around the world.
Here, you will be an important contributor to our inspiring, bold mission. GOALS:
- Lead and direct implementation of important, time-sensitive, and complex projects within Takeda R&D, including compliance with the new European Union (EU) pharmaceutical legislation known as the Clinical Trials Regulation (CTR).
- Lead project progression including managing collaboration among Takeda partners, and working with external partners (e.g., regulatory authorities, CRO partners).
- Facilitate change management to ensure sustainable project implementation.
- Monitor project status and communicate progress throughout the organization.
- Implement Takeda R&D's projects to ensure compliance to the new EU regulations known as the EU CTR.
- Be the point-of-contact for implementing process and organization changes affecting multiple responsibilities and CRO partners related to the submission and maintenance of clinical trial applications (CTA) in compliance with the EU CTR.
- Lead the transition of all impacted clinical programs across Takeda therapeutic areas to the Clinical Trials Information System (CTIS) following the required timeline.
- Support identified early adopter studies with their transition and gather lessons-learned to be shared with the broader impacted study teams and tasks.
- Develop and launch trainings for directly impacted roles including study teams, other Takeda R&D functions, and CRO partners on the new regulations and changes to their responsibilities.
- Engage partners in change management efforts to ensure adoption of the process and organization changes related to EU CTR compliance Develop and launch communication to lead awareness of the new EU regulation in the broader R&D organization.
- Manage CTIS portal administration, management, submission, and tracking.
- Mobilize and prepare impacted study teams' preparation for potential RFIs across the study timeline.
- Facilitate study teams' response to EU regulatory inquiries within required timeline.
- Gather and codify best practices from Takeda experiences and industry insights with EU CTR.
EDUCATION AND EXPERIENCE:
- Implement other initiative involving wide range of partners.
- For each initiative, responsibilities will include:
- Define implementation roadmap (timelines, milestones, etc.).
- Develop and track metrics for internal reporting.
- Identify and mobilize partners including external parties (e.g., regulatory authorities and CRO partners).
- Ensure progression of projects following the project plan and provide periodic progress reports to leadership or other impacted partners.
- Develop and implement change management initiatives to equip impacted partners with relevant knowledge to sustain change.
- Provide expert counsel for issue resolution, including projects assigned to other staff.
- Support role of Senior Director, Clinical Operations.
- Bachelor's Degree or international equivalent required, Life Sciences preferred.
- 10+ years' experience in pharmaceutical industry or clinical research organization, including 5+ years' experience in clinical development.
- Leadership experience in large-scale, implementation and change management projects required.
- Demonstrated excellence in leadership and project management, including creative operations approaches to achieving program goals.
- Expertise in clinical trial management, regulatory, or study startup.
- Experience with EU regulations, in particular understanding of EU CTR.
- Relevant IT systems knowledge preferred (Veeva Regulatory and Clinical Vaults, Excel)
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply. Base Salary Range: $160,000 - $229,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq.
This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy. 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
Massachusetts - Virtual Worker Type
Employee Worker Sub-Type
Regular Time Type