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Accountable for all aspects of assigned OGD clinical trials including leading Clinical Trial Team(s) (CTT). Number of clinical trials depends on the workload and complexity of the individual trials. Responsible for program level activities as assigned.
1. Accountable for the writing of clinical protocols and related documents in collaboration with the GCPH, GCL, and/or MSE,: 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. Participate in development of effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards. 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.
3. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: 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 GCPH, GCL, and/or MSE,, 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 to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the Contract Management Department.
6. Forecast trial resources needs (headcount and external costs): accountable for the development, management and tracking of trial budget working closely with the appropriate groups in Oncology (e.g. CRO management, POM). Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TA management to ensure appropriate line function allocation.
7. In collaboration with the Lead CTH, assign short to mid-term responsibilities to CM who assist in the planning, conduct and reporting of clinical trials; independently manage the day-to-day interactions with the CMs.
8. Accountable for overall management of CMs. Identify training needs to foster high level of performance, support career development through quality development plans. Proactively manage performances issues. Establish annual objectives according to OGD priorities.
9. Contribute to the develo pment of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.
10. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier.
11. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
12. Participate in the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for OGD training programs.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. Our policies are not to discriminate in recruitment, hiring, training, promotion or 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.
This position will be filled at a level commensurate with experience.
Bachelor of Sciences in life science/healthcare is required. Advanced degree in Sciences is preferred.
Languages: Fluent English (oral and written).
1. 4+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.
2. Proven ability to work independently, plus to lead a multidisciplinary trial team in a complex matrix environment (including remote). Will have direct reports.
3. Experience in developing effective relationships with key investigators.
4. Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
* Oncology experience is strongly desired.
* Direct-report people management experience also strongly preferred.