Head of Clinical Operations
Novartis Farma IT
Origgio, Italia
4 gg fa

Job Description

50 is the number of countries in which we have the opportunity to place Novartis late phase clinical studies in Region Europe.

100’s are the number of potential investigators asking us to support their studies and more than 700 Million is the population potentially waiting for the results of our work.

We are Medical Affairs, Novartis Oncology Region Europe and proud to be an integrated part of the Oncology Business unit co creating strategy and tactics with countries and Global and being a servant leader in the execution of tactics, e.g. regional trials

Job Purpose

Provide strategic and operational expertise for the timely, quality preparation and execution of the regionally and selected multi country sponsored clinical development program (Phases I -

IV). Management and optimization of resources and development strategy across multiple projects within Oncology Region Europe (Phase II IV).

Supervise the internal aspects of the coordination of Investigator driven projects in the Region. Coordinate the internal aspects of Managed Access Program infrastructure.

Major Activities

1. Build and implement high-quality standardized processes across European teams dealing with the operational implementation of studies

2. For Study support , coordinate teams of Medical Science Liaison (MSLs) and / or their managers.

3. Works cross-functionally with other Novartis departments to develop aligned strategic plans for the optimal dissemination of clinical evidence by the teams of MSLs in pre and post product launch phases in accordance to local health authority guide- lines.

4. Accountable for the implementation and execution of Clinical Ops product- specific strategic and tactical plans. 5. Optimize Clinical Operations contribution to the CPO cross functional product teams.

6. Drive the consolidation of KOL and key account insights to support the development of the Medical Affairs and CPO product strategies.

Accountable for Dashboard of activities generation across all ORE IIT’s ORE sponsored studies, selected Global projects and Event activities

7. Oversees all aspects of recruiting, hiring, on-boarding, including scientific & functional training,

8. Optimize resources across therapeutic teams and / or geography to align with CPO business 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 and other departmental spending.

11. Coordinates Operational staff responsible for Meeting organization, Event Management etc

12. Consistently ensure a seamless interface between the Medical Affairs, Mktg and Market Access teams.

13. Contribute to the Global Medical Affairs’ objectives

14. Ensure synergy across Regional projects, regardless of location.

15. Contribute clinical and strategic input into the Clinical Development Plan

16. Oversee day-to-day operations for section and ensure adequate staffing of projects.

17. Contribute to strategic portfolio management.

18. May serve as the clinical representative on International Project Team.

19. Contribute senior level expertise for licensing reviews. 20. Commitment to develop people, process, innovation and external focus.

21. Represent ORE with indication specific expertise in selected settings

22. Liaises with GMA GxP compliance and supports Global, region and countries to deliver studies in GxP compliance. Compliance for Medical events rests with Business owner

Minimum requirements

Experience / Professional requirement :

1. Minimum 10 years experience in clinical research.

2. Knowledge of advanced clinical trial design, statistics and pharmacokinetics.

3. Successful function as a Clinical Program Leader / Clinical Indication Leader / Medical Brand Director in international development, or comparable experience.

4. Proven competence in developing strategic capabilities.

5. Proven ability to interpret, discuss and represent efficacy and safety data relating to assigned area and provide recommendations on the project level.

6. Proficient in all aspects of the drug development process including commercialization.

7. State-of-the-art clinical research knowledge of assigned area.

8. Excellent knowledge of GCP and world wide regulatory requirements relating to assigned area.

9. Proven ability to manage cross-functional teams in complex projects.

10. Proven ability to analyze, interpret and report efficacy and safety data in several area of medicine.

11. Superior leadership skills, including demonstrat

ability to effectively lead, coach and manage field- based scientific / medical professionals.

12. Strong knowledge of all aspects of drug development.

16. Thorough understanding of internal / external ethical guidelines relevant to the pharmaceutical industry.

17. Excellent interpersonal, communication, negotiation and presentation skills.

18. Strong personal integrity, teamwork abilities, and a customer focus are necessary.

19. Must be able to organize, prioritize, and work effectively in a constantly changing environment and to motivate a team to do the same.

20. Demonstrated ability to work in a cross functional & international environment.

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