The Associate Director, Clinical Operations IIT (Investigator Initiated Trials/MAP Champion will provide strategic and tactical support for US Clinical Operations organizations within US Clinical Development and Medical Affairs. Represent US CDMA to the Global IIT and MAP project teams, align process and tools with US Oncology IIT and MAP programs, act as the single point of contact for the relevant stakeholders in US CDMA. US CDMA liaison with GMA for US CDMA IIT and MAP process, regulations and governance. Supports both US Clinical Development and US Medical Affairs teams to assure compliance with GOP, WP, WPD for Investigator Initiated Trials and Manage Access Programs.
*Responsible for local IIT and MAP operational governance.
*Active workstream participation with IIT and MAP Global Governance to ensure GOP policy decisions fit US regulations and operational framework.
*Develop US specific IIT and MAP processes that align US process with GOPs. Align process with other US divisions and ensure consistency for common internal and external business partners.
*Actively champion end to end oversight and continuous process improvement. *Ensure alignment of IIT and MAP process with other processes.
*Drive the implementation of the new IIT system and MAP portal, internal business controls and related training locally.
*Communicate all key updates from the IIT and MAP Office to identified stakeholders across multiple US CDMA and partner functions.
*Ensure governance and oversight is established and maintained on IITs, MAPs and relevant topics.
*Drive and track implementation of IIT and MAP project deliverables including remediation activities and other relevant projects.
*Work with Clinical Teams to identify appropriate MAP strategies within large clinical programs and individual clinical trials.
*Operational Leader and guide for Clinical Operations teams for local MAP programs.
*Responsible for developing, tracking and reporting metrics on US CDMA IITs and patient access programs post clinical trial and reporting to CDMA LT.
*May be involved with special projects and work streams related to Clinical Operations line function.
*Responsible for leading CDMA team of SME in the areas of IITs and MAP programs.
*Accountable for internal audits, US CPO self-inspections and related-remediation activities for IITs and MAP programs. Provides updates to CDMA LT.
*Collaborates with QA on HA inspections for IITs and MAP programs.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Bachelor Degree in scientific or healthcare discipline is preferred, (preference for Sciences), advanced degree desirable
Excellent English written and verbal communication skills.
7 years working directly in the area of clinical trial execution with country and/or global experience
Excellent understanding of all aspects of clinical drug development
Strong project management skills
Demonstrable experience in the management of IITs;
Demonstrated leadership across cultures with the ability to influence and direct others within a matrix environment
Familiar with general health authority, GCP and ICH requirements
Ability to communicate and build relationships at all levels within the organization
Excellent communication and presentation abilities and skills.
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