Responsible for management of all aspects and ensuring high quality of assigned clinical trials (phase I-IV, Expanded Access, registries, and Compassionate Use) including leading Clinical Trial Team(s) (CTT). Conducts required tasks in collaboration with GBMD and other line functions. Responsible for program level activities as assigned with an entrepreneurial approach which requires the ability to multi-task on a wide spectrum of activities with an overall external focus
1. Ability to manage phase I-IV clinical trials including EAP, Compassionate Use and non-interventional studies. Accountable for the writing of clinical protocols and related documents in collaboration with the GBMD,: lead the clinical trial protocol development process; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors and Advisors of the major Novartis local medical organizations to ensure country feedback is adequately integrated into protocol.
2. Support the GMA medical director in development of effective working relationship with investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related scientific meetings. Lead investigators meetings. Lead protocol training meetings to support Novartis local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical trial. Develop effective working relationships with stakeholders.
3. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards, SOPs and Business Guidance; chair CTT meetings, report study progress and issues with their resolution plan to International Clinical Teams; lead trial level interactions with Oncology Development Operations and other relevant functions including Drug Supply Management and Novartis local medical organizations
4. In collaboration with the GBMD, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
5. Develop clinical outsourcing specifications (SSW) incorporation with respective line functions to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Contract Management Department
6. Accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology. Accountable for accuracy and timeliness of trial information in all trial databases and tracking systems.
7. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, safety updates, etc....
8. Manage the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for training programs.
9. Manage third-party Investigator Initiated Trials (ITT), Regional and Locally Sponsored Novartis Trials – provide feedback on study proposals, review submitted study concepts/protocols for core requirements via the Study Express System. Collaborate with local CPOs and regions to track study progress, update databases and manage budget. Ensure compliance with Novartis SOPs, Business Guidance and regulatory requirements. Experience with cooperative group studies beneficial
10. Implement Individual Patient Support Program as assigned. Manage physician request, provide treatment plan guidance, ensure compliance with SAE reporting, and manage drug supply. Awareness of local regulatory requirements. Ability to manage Expanded Access programs
11. Participate in assigned initiatives
12. May supervise other team members as assigned in collaboration with the GBMD. Assign short to mid-term responsibilities. Identify training needs to foster high level of performance, support carrier development through quality development plans. Proactively manage performances issues. Establish annual objectives according to GMA priorities.
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Bachelors Degree in health or life sciences
Fluent English oral and proficient technical written skills
• = 5 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
• Proven ability to work independently, as well as ability to collaborate and work effectively in teams. Ability to lead a multidisciplinary trial team in a complex matrix environment and build effective relationship with stakeholders
• Demonstrate effective Project Management skills as well as ability to prioritize based on business need
• Thorough knowledge of Good Clinical Practice and clinical trial design. Immediate statistical and regulatory process knowledge required. Experience with complex or randomized studies
• Working knowledge hematology/oncology/endocrinology knowledge of therapeutic area is preferred.
• Experience developing effective relationships with investigators.