US-NJ, Director, Excellence and Innovation 235225BR-MZ
Director, Excellence and Innovation
East Hanover, NJ
Research & Development
Accountable for supporting the Global Head of GMA Clinical Operations in the creation of clinical trial standards across GMA/OMA programs to develop, drive and sustain clinical trial excellence and innovation. Operational Leader of the GMA PRC ensuring quality and timely review of protocol synopsis, protocols, amendments and consent forms. Expert on clinical trial processes, Investigator Initiated Trials (IITs) and Managed Access Programs (MAPs). Serves as an additional support to the GMA Clinical Teams as needed. Can also serve as delegate to the Global Head GMA Clinical Operations as needed.
1.Subject Matter Expert for clinical operation processes. Assist in the development of a functional center of excellence and innovation in clinical trial execution, IIT review and approval process and MAP governance in GMA and across Oncology Medical Affairs (OMA).
2.Assist the Global Head GMA Clinical Operations with addressing potential quality issues, clinical trial issues, supporting the prioritization of resources based on project needs and any other activities needed to ensure the execution of clinical trials and other GMA Clinical Operations activities with quality and in close collaboration with other line functions and external partners.
3.Contribute to the development and review of clinical SOPs/GOPs and Working Practices as needed. Assess SOPs/GOPs for potential operational gaps and raise issues to GMA Leadership Team.
4.Assist in maintaining high quality standards as defined by CQA (Critical Quality Attribute) Quality Plan. Provide recommendations for improving productivity. Collaborate with GMA Medical Business Operations & Functional Excellence group in compiling Key Quality Indicators for GMA/OMA Clinical Operations.
5.In collaboration with GMA Medical Business Operations & Functional Excellence, serve as resource for internal audits and external inspections for GMA/OMA activities and trials.
6.Champions cross-functional initiatives and innovations while representing GMA Clin Ops to ensure alignment
7.Ensures awareness of new trends in the industry, evaluating new technologies, supporting implantation and driving operational excellence
8.Represent GMA Clinical Operations in functional or cross functional initiatives.
9.Accountable for the GMA Clinical Operations staffing activities including screening and allocation of third party contractors, internal resources and PLS resources across project teams.
10.Serves as a member of the GMA Clinical Operations Leadership team as needed.
11.As operational leader of the GMA Protocol Review Committee (PRC) responsible for organization of regular PRC meetings.
Timely review of protocol documents (protocols, amendments, MAP treatment plans and consents) that are submitted through a web based application, PRC Document Tracker
Keep meeting minutes and issue them through PRC Document Tracker
Verify the protocol based on the Protocol Checklist for past meeting action items and approve within the protocol timelines after the GMA PRC review of the synopsis
Review documents for quality and consistency prior to finalization
12.Interact with Clinical Operations team and provide guidance during protocol authoring on items such as template requirements; Clinical Trial Protocol (CTP) process, GMA PRC submission/review process and program specific language as needed.
13.Support GMA/OMA metrics gathering especially clinical trial metrics and metrics related to KPI/KQIs.
14.Ensure GMA Oncology Clinical Operations processes are aligned with GMA Pharma and Global Drug Development (GDD) as applicable.
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.
Degree in health or life sciences, advanced degree or equivalent preferred
8 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization
Demonstrated effective Project Management skills as well as ability to prioritize based on business need. Proven leadership in complex matrix organization with global line functions including; health economics, safety, marketing, life cycle management, new product strategy, medical liaisons, medical information, scientific communications
Expert knowledge of Good Clinical Practice, protocol design, statistics, and regulatory processes. Multinational/global trial experience required.
Extensive working knowledge hematology/oncology/endocrinology is preferred.
Demonstrated ability to establish strong scientific partnership with key investigators and complex organizations such as cooperative groups and large institutions
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