US-NJ, GMA Franchise Clinical Operations Head 229753BR-MZ
GMA Franchise Clinical Operations Head
East Hanover, NJ
Research & Development
Leads planning, execution and management of the assigned GMA Franchise Clinical Operations activities to achieve Oncology Medical Affairs (OMA), Global Medical Affairs (GMA), GMA Franchise and Global Program Team (GPT) objectives. Oversight of budget and resource allocation within assigned Franchise including broader review of resources in collaboration with the Global Head GMA ClinOps. May act as GMA ClinOps representative on GPT. Drives operational excellence through process improvement and knowledge sharing across therapeutic areas within Franchise. Enables an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs. Point of escalation for resolution of Franchise operational issues.
1.Resource and Budget Management:
Ensure optimal resourcing across trials within Franchise to meet business needs according to OMA portfolio prioritization
Collaborate with Franchise Head on budget including forecasting and reconciliation within Franchise
Collaborate with the Global Head GMA ClinOps on headcount requests and resource management in alignment within the ClinOps team and other line functions as required
Lead trial prioritization activities within Franchise across OMA in collaboration with Franchise Head
Full accountability for setting up Franchise clinical work packages in collaboration with Global Program Project Manager
2.Franchise level planning and execution:
Key contributor to operational strategy within Franchise; provide global clinical operational input into Integrated Evidence Generation Plans for assigned Franchise
Oversee ClinOps involvement in Integrated Disease Medical Teams within the Franchise
Oversee timely and efficient program execution according to the approved Integrated Development Plan
Establish Franchise priorities in alignment with regions and countries across OMA
Develop and ensure implementation of operational program-specific standards as required to enhance consistency within Franchise and across GMA Clinical Operations
Ensure trials within Franchise are conducted in accordance with SOPs and all deliverables are met according to timelines, budget, quality standards and operational procedures
Ensure Investigator Initiated Trials and Managed Access Programs are conducted in accordance with SOPs in collaboration with the Regions and countries
Ensure ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations for studies within the Franchise
3.May act as GMA ClinOps representative on GPT.
4.Act as point of escalation for resolution of trial management and operational issues within assigned Franchise.
5.Collaborate with relevant line functions by developing and implementing process standards and tools to achieve excellence in trial management. Drive process improvement in collaboration with other GMA Franchise Operation Heads and Franchise Head. Co-chair Trial Management/Franchise forums as required.
6.Provide oversight on quality and compliance in conjunction with the GMA Global Head of Medical Business Operations and Functional Excellence.
7.Build best talent and an empowered culture to foster high performance in a matrix environment. Assess needs of the organization to improve the medical/scientific, operational and budget management capabilities in assigned Franchise, in alignment with the Franchise Head and other GMA Franchise Operation Heads.
8.Serve as knowledge source for Trial Management associates and coordinate knowledge sharing within OMA, GMA and assigned Franchise.
9.Author/reviewer for relevant SOPs.
10.Lead or represent GMA Clinical Operations in functional or cross functional initiatives.
11.Core member and active participant on the GMA Clinical Operations Leadership Team.
12.Support Global Head GMA ClinOps in establishing and maintaining close and effective relationship with Clinical Operations in OMA, Global Drug Development, and Pharma.
Key Performance Indicators
1.Timely, efficient and quality execution of Franchise related activities within budget, and in compliance with quality standards.
2.Appropriate funding and resourcing for clinical program(s)/clinical trials within the Franchise.
Number of Associates:Direct: 2-5 (GMA Franchise Trial Directors)
Indirect: 5-25 Trial Management associates for assigned clinical program(s).
Financial responsibility:Internal budget accountability for direct reports.
External budget accountability for clinical trials in assigned Franchise.
Impact on the organization: Drive operational excellence.
Achieve results faster, with higher quality and efficiency in cooperation with key stakeholders.
Optimize resourcing and allocation of associates across organization.
Recruit and develop talent to achieve a high performing Trial Management organization.
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.
Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD preferred).
Fluent English (oral and written)
10 years of pharmaceutical clinical research experience.
5 years people management and development experience required, this may include management in a matrix environment. Global people management experience is desirable.
Demonstrated leadership and accomplishment in all aspects of conducting global clinical trials and programs.
Extensive knowledge of clinical development process, GCP and clinical project management. Novartis experience in these areas is preferred.
Excellent interpersonal, problem-solving, negotiation and conflict resolution skills.
Organizational awareness, including significant experience working cross-functionally and in global teams.
Proven track record in trial operations process improvement(s).
Proven record of managing resource including planning (budget and headcount).
Proven track record in trial operations process improvement(s).
Strong knowledge of appropriate therapeutic area preferred.
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