- Provide leadership and expertise in the global clinical operational strategy, directing project teams to support the clinical studies defined in the Integrated Clinical Development plans for compounds within assigned Therapeutic Area ensuring all studies are executed in accordance with Code of Federal Regulations, Good Clinical Practices, ICH Guidelines, and all applicable local regulations.
- Responsibility for the development and management of all operational timelines and budgets in excess of 100 million dollars for assigned therapeutic areas. Identifies issues that may impact the overall program plan (quality/timelines/cost) and initiates contingency plans as appropriate
- Responsible for the direct management of senior manager team members. This position also has indirect management responsibility for Sr. CTM/CTM positions.
- Takes a lead role in the development of innovative processes and technologies to advance operations and reduce overall operating costs. Works in close collaboration with other Clinical Operations colleagues to ensure consistent incorporation of best practices across all therapeutic areas
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- This position will be aligned to one or several vaccine programs of VBD and providing operational strategy. Depending on the number of compounds/studies and complexity the position may span an additional therapeutic area.
- Responsible for active input on Global Feasibility teams, providing leadership and expertise in the clinical operational strategy for new compounds
- Responsible for active input on Global Development Teams providing expert operational strategy
- Provide expert operational and strategic input into Integrated Development Plans, study synopses, protocols, and clinical study reports
- Anticipate and identify operational risks that may impact program quality, timelines or budget and ensure contingency plans are in place
- Oversee all financial forecasting and potential issues with clinical study budgets for programs within assigned therapeutic area. Ensure timely implementation of appropriate solutions.
- Oversees and directly manages senior manager team members’ day-day operational execution activities ensuring consistent incorporation of best practices. This position also has indirect management of Sr. CTM/CTM positions.
- Performs regular performance assessment of Program Managers providing coaching and mentoring
- Identifies and addresses all operational issues with Program Managers
- Develop, utilize and maintain resource models to ensure clinical personnel workload is allocated efficiently and effectively within assigned therapeutic area.
- Makes recommendations on long term resource and budget planning for assigned therapeutic area.
- Ensure the successful completion of Program Manager training activities related to Takeda’s SOPs, policies, ICH Guidelines, and other regulatory, statutory, and best practices for clinical personnel
- Interfaces with Clinical Operations VP, Directors, Associate Directors and functional disciplines and personnel directly or indirectly involved in the effective management of clinical trials to optimize performance of clinical personnel and clinical development
Education & Experience:
Knowledge & Skills:
- Bachelors Degree required, Life Sciences preferred. Advanced degree highly desirable.
- 9+ years of clinical development or trial experience in the pharmaceutical industry or in a clinical research organization required.
- 6+ years of clinical trial management in any of Phases I-IV required.
- 4+ years of line management or matrix management required.
- Phase II/III experience preferred.
- Global/international experience preferred.
- Drug development experience across multiple therapeutic areas preferred.
- Expertise in Code of Federal Regulations, Good Clinical Practices, and ICH Guidelines.
- Must be able to make strategic decisions for the operational plans within assigned therapeutic area
- Exhibit excellent independent judgment and have a clear understanding of what issues need to be elevated
- Excellence in project management and leadership skills
- Excellent teamwork skills
- Creative thinking skills
- Strong negotiation and persuasion skills
- Excellent self-management, organizational and verbal/written communication skills
- Enthusiasm for innovative research and ability and desire to learn new approaches and expand core skill set
- Strong understanding of finance principles and the ability to use financial knowledge to make sound operational decisions
We are driven to improve people's lives.
- Access to transportation to attend various meetings held in proximity to the Takeda offices.
- Able to fly to various meetings at investigator, vendor or regulatory agency sites.
- Some international travel will be required.
We are an equal opportunity employer.
No Phone Calls Or Recruiters Please.