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Job Purpose     

Accountable for all aspects of assigned TCO medium to high complex clinical trials (Phase I/II) including leading Clinical Trial Team(s) (CTT). Responsible for program level activities as assigned. 

Major Accountabilities     

1. Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for medium to highly complex clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trialrelated documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Novartis local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.

2. Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates, IND/NDA submission documents, responses to Health Authorities questions.

3. Investigator/site relationship management is vital; must develop 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 and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).

4. Lead and matrix manage the global multidisciplinary CTT with minimal supervision to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management.

5. In collaboration with the CPL 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.

6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings and Phase II data reviews with investigators.  

7. Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program and TCO management to ensure appropriate line function allocation.

8. Sits on Early Program Team (EPT) to contribute to program strategy.

9. Lead or be a key contributor to the development of program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK,, data monitoring, validation plans and data transfer specifications), where applicable. Ensure that these are applied across all trials to ensure consistency of clinical dossier.  

10. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed for the clinical trial(s).

11. For TCO trials function as local trial leader (LTL) for all US activities supported by the CPA, including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments. As the LTL, be the primary contact for US sites for clinical conduct of the trial.

12. CTLs based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China supported by the CPA.

13. Participate in the hiring, on-boarding, and training of new staff. Mentor TCO staff. May serve as faculty member for training programs.

14. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned.

15. Represent TCO ClinOps on initiatives; serve as Subject Matter Expert as appropriate.

Key Performance Indicators      

Planning, executing and closing of medium to high complexity early phase trials on time and within budget

Adherence of GCP/ICH to ensure high quality trial conduct

Ongoing data review to promote trial decisions and strategic planning

Contribution beyond trial team through departmental initiatives, presentations, mentoring, hiring of new associates

Education: Advanced degree or equivalent education/degree in life science/healthcare strongly recommended..

Languages: Fluent English (oral and written)

Experience: 

6 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.

Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.

Advanced knowledge of oncology and/or hematology, OR experience in early clinical development.

Hands-on experience in patient data review, cleaning and analysis required.

Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).

Proven experience in developing effective relationships with key investigators.

Education: Advanced degree or equivalent education/degree in life science/healthcare strongly recommended..

For more information, Please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960