US-NJ, Regional Clinical Operations Head LACAN 222610BR-MZ
Regional Clinical Operations Head LACAN
East Hanover, NJ
Research & Development
Provide strategic and operational expertise for the timely, preparation and execution of the regional clinical plan/trials in compliance with Novartis processes.
Accountable for leading and line-managing a team of RCTHs and/or RCTMs in charge of all the regional trials in the Region. Responsible for the oversight of the Local trials and IITs prioritization, if applicable in the region. Accountable for the regional clinical trial budget.
Management and optimization of resources and development strategy across multiple projects within the region.
1. Accountable for the implementation and execution of Clinical Operations product- specific strategy and tactical plans.
2. Optimize cross functional clinical operations contribution of the CPO to ensure success of regional trials and in alignment with global
3. Participates in hiring, on-boarding and training of new regional operational associates
4. Optimize resources across therapeutic teams to align with Regional Medical Affairs priorities
5. Main oversight of Phase IV clinical activities in the Region, including IITs, RWE trials and Local trials, from concept sheets to publications.
6. Prioritize IITs and local trials in collaboration with the Regional Medical Director
7. Accountable to keep the track of the publications, papers, posters and abstracts presentations coming out from Region (publication plan and status)
8. Accountable for overall management of RCTHs/RCTMs. Identify training needs to foster high level of performance, support career development through development plans. Proactively manage performances issues. Establish annual objectives according to Regional priorities.
9. Ensure the identification and implementation of effective technology enablers to continually enhance the productivity of the team.
10. Responsible for developing and managing the Clinical Operations budget including review and approval of expense reports
11. Lead Regional interactions with GMA Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations.
12. Collaborate with the outsourcing/purchasing manager to develop clinical outsourcing specifications and contribute to the selection of CROs; manage interface with CROs
13. Consistently ensure a seamless interface between the Medical Affairs, Marketing and
Market Access teams in collaboration with the Regional Medical Head
14. Contribute to the Global Medical Affairs objectives through active collaboration and best practice sharing with Global, Clusters and Countries Clinical Operations teams.
15. Ensure synergy across Regional projects, regardless of location.
16. Contribute clinical and strategic input into the Regional Clinical Plan.
17. Oversee day-to-day operations and ensure compliance with policies and processes
18. Responsible for implementation of best practices and standards for trial management within the regional trials scope, including sharing lessons learned.
19. May serve as the clinical representative on International Project Team.
20. Committed to develop people, processes, innovation and external focus.
21. Work and represent region with global oncology governance boards and lead implementation of guidance initiatives.
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.
Languages: Fluent English (oral and written)
1. Minimum 10 years experience in clinical research.
2. Knowledge of advanced clinical trial design, statistics.
3. Proven competence in developing strategic capabilities.
4. Proven ability to interpret, discuss and represent efficacy and safety data relating to assigned area and provide recommendations on the project level.
5. Proficient in all aspects of the drug development process.
6. Medical/scientific and state-of-the-art clinical research knowledge of assigned area.
7. Excellent knowledge of GCP and regulatory requirements relating to assigned region.
8. Proven ability to manage large cross-functional teams in complex projects.
9. Proven ability to analyze, interpret and report efficacy and safety data in several area of medicine.
10. Superior leadership skills, including demonstrate ability to effectively lead, coach and manage the associates.
11. Strong knowledge of all aspects of drug development.
12. Proven innovative and critical thinking with performance-oriented drive.
13. Thorough understanding of internal/external ethical guidelines relevant to the pharmaceutical industry.
14. Excellent interpersonal, communication, negotiation and presentation skills.
15. Strong personal integrity, teamwork abilities, and a customer focus are necessary.
16. Must be able to organize, prioritize, and work effectively in a constantly changing environment and to motivate a team to do the same.
17. Demonstrated ability to work in a cross functional & international environment.
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