Pharmaceutical / Biotech
Research & Development
Location: Indianapolis, IN
The Ideal Candidate:
5+ to 7 years of experience
Management Experience Required – Yes
Minimum Education –Master’s Degree
Willingness to Travel – Occasionally
The Clinical Trial Support Operations (CTSO) team is responsible for providing clinical trial study drug management services and supporting the Demand Management side of the business by providing the following support services: Distribution, Study Order Management and Ownership, and Business Systems Support & Operations. The Clinical Trial Support Operations team partners with appropriate business partners to ensure study order ownership and support to successfully enable clinical research.
The Director is responsible for developing and implementing the strategy for the Clinical Trial Support Operations department, effectively managing the capacity and capabilities of the organization, ensuring strong cross functional partnerships exist in support of the portfolio, and overseeing compliant business processes and deliverables that lead to the on time delivery of Investigational Products that enable Clinical Research. The Director provides appropriate oversight to ensure full compliance with GxP, corporate standards/policies/procedures, operational excellence, continuous improvement, personnel development and overall leadership.
KEY OBJECTIVES/DELIVERABLES:
Execute all position responsibilities in a way that integrates ethics and compliance and follows all applicable regulations, the Corporate Integrity Agreement, The Red Book, and policies related to job content.
Management
- Accountable for the global business operation process and execution of the CTSO group
- Provide leadership, direction and oversight for -50 people in Indianapolis, Indiana and Brussels, Belgium
- Organize the department so as to reach the fixed objectives. Recruit the necessary employees and ensure their training. Foster the development of technical and organizational expertise. Forecast adequate budgets and manage the department accordingly.
- Ensure that CT material is produced and supplied on time and in compliance with the quality standards and regulatory requirements (FDA, EMEA, ICH)
- Ensure the appropriate facilities, buildings and equipment are available
- Develop effective relationships with the customers and business partners
- Accountable for delivery of information and services to support the global clinical development strategy.
- Drive continuous process improvement and increased efficiency
- Accountable for all aspects quality and compliance
- Effectively manage all communication channels
- Anticipate and resolve issues with the organization and key stake-holders
- Accountable for operational leadership and excellence
- Accountable for development and communication of objectives as well as execution against the objectives
- Accountable for ensuring development of operations skills and capabilities.
- Accountable for implementation and utilization of all supply chain management principles and practices.
- Strategy
- Develop the Vision and associated strategy and plans to successfully deliver all CTSO responsibilities
- Responsible for contributing to and leading the organization to deliver the CTMS vision and strategy.
- Foster and support continuous process improvements
- Support all aspects of the CTMS transformation agenda
External Focus
- Maintain and foster contacts with the other global functions in Indianapolis and ELECTS (CTMM, outsourcing, packaging, quality, manufacturing, etc.)
- Create relationships with customers and external organizations or other pharmaceutical companies (benchmarking).
- Leverage the academic environment to foster innovation.
- Promote the participation of employees in external activities, congresses, seminars that will allow them to exchange professional information.
- Actively manages relationships with external business partners to ensure a positive and productive working environment and enable a FIPNET working environment
- Provide an external focus through appropriate interaction with other departments; seek to understand trends in the CT supply business.
MINIMUM REQUIREMENTS:
B.S. in Scientific, Operations or related field with 7-10 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 5-7 years experience in people management
OR
Advanced degree (e.g., PhD, PharmD, M.S. Management, MBA) with 5-7 years experience in pharmaceutical drug development with expertise in at least 1 of the following areas: Product Research and Development (PR & D), Manufacturing, Clinical and 3-5 years experience in people management
