Program/Project Responsibility

1.May provide clinical leadership and strategic input for all clinical deliverables across assigned indication/program or studies within BR. May act as Focus/Disease/Platform Area Lead.
2.May function as a Core Project Team member for assigned projects to drive the R-D-C continuum. May co-lead project clinical sub-team and reports study/project progress and issues with their resolution plan to project teams and stakeholders. Directs early stages of study design and operational plans.
3.Study Leader and/or Clinical Scientist for predominantly high complexity, global studies and may provide additional Clinical Sciences support to high priority, high complexity, global studies.
4.Independently lead the clinical protocol development process incollaboration with the Medical Lead and other line functions; responsible author for clinical protocols, amendments, etc.; contribute to the medical/scientific input given for the development of study-related documents and processes which resides in other line functions; contribute to the development of clinical sections of study-level regulatory documents.
5.Lead development of strategic and scientific input into study concept, feasibility, and ability to execute; develops and implements study-level operational execution plan in partnership with key cross functional partners, if applicable.
6.Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
7.Lead a global cross functional CTT to ensure all trial deliverables are met; sets stretch goals, promotes realistic planning and timelines, and presents actionable alternatives to accelerate timelines.
8.Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
9.Lead the ongoing medical/scientific review of clinical trial data across assigned studies in collaboration with the medical expert and key line functions, and partners on data analysis and data interpretation, including safety trend analysis, signal detection, development of first interpretable results, reporting clinical study results in CSR, and internal/external publications.
10.Prepare and lead dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, to provide consolidated information for dose escalation meetings and Phase II data reviews with relevant stakeholders.
11.Proactively lead risk mitigation discussions, risk management and implementation at the trial level.
12.Responsible and accountable for forecasting and managing overall study budget(s) in collaboration with key partners.
Head of TCO Japan
13. Collaborate with key partners to set vendor strategy and timelines for assigned studies.
14. Responsible for implementation of best practices and standards for trial management, including sharing lessons learned. Represent group on initiatives; may serve as Subject Matter Expert
15. Contribute to talent and career development of staff. In collaboration with the relevant manager, contributes to hiring/interview/onboarding and mentoring process for new hires.
16. Line management of assigned associates. Accountable for talent attraction and retention; supporting career growth and development.
17. May deputize for his/her manager upon request.

For associates based in China and Japan, develop local early development strategy, lead local study activities throughout the study lifecycle, may serve as a regional BR liaison for scientific research activities, if required.

Impact on the Organization

Responsible for the availability of high quality, Biomedical Research data according to agreed timelines and budget to enable no delays in strategic decision making and drug registration. External impact: Novartis perceived as a credible, ethical and preferred business partner.

Minimum Requirements/Skills

- Bachelors in life science/healthcare required; Advanced degree or equivalent education/degree in life sciences/ healthcare preferred (PhD/MD/ PharmD/ Masters).
- Approximately 8+ years’ experience in clinical trials/development.
- For TCO: Strong understanding of oncology/hematology and demonstrates high learning agility.
- For TM: Demonstrates high learning agility in multiple therapeutic areas.
- Demonstrated knowledge and ability to confidently drive complex collaborations through unpredictable circumstances and higher paced changes.
- Demonstrates strong organizational awareness and stakeholder management skills.
- Demonstrate strong tolerance for ambiguity, willingness to adapt, and willingness to speak-up and challenge.
- Proficient in clinical trial methodology with an emphasis in early clinical development. Strong operational project and program management experience with an emphasis in early clinical development, including excellent planning, prioritization, problem solving and organizational skills.
- Track record of successfully leading multiple complex clinical trials concurrently. Used to managing multiple priorities.
- Demonstrated capability to interpret, discuss and represent trial level data.
- Good working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.
- Maintain expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.