Program/Project Responsibility

1.Study Leader and/or Clinical Scientist for predominantly low complexity, global studies and may provide additional Clinical Sciences support to high complexity, global studies.
2.Lead or support 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.
3.Support 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.

4.Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
5.Lead or support 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.
6.Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
7.Lead or support 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.
8.Prepare, lead or support dose escalation meetings with investigators.Coordinate the real time availability of quality clinical trial data, toprovide consolidated information for dose escalation meetings andPhase II data reviews with relevant stakeholders.
9.Proactively lead or support risk mitigation discussions, riskmanagement and implementation at the trial level.
10.Responsible and accountable for forecasting and managing overallstudy budget(s) in collaboration with key partners.
11.Collaborate with key partners to set vendor strategy and timelines forassigned studies.
12.Responsible for implementation of best practices and standards fortrial management, including sharing lessons learned. Represent Groupon initiatives; may serve as Subject Matter Expert.
13.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.

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 2+ years’ experience in clinical trials/development
▪ For TCO: Strong understanding of oncology/hematology and demonstrates high learning agility.
▪ For TM: Demonstrates high learning agility.
▪ Demonstrated ability to drive collaborations through unpredictable circumstances and higher paced changes.
▪Demonstrates 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. Operational project management experience including excellent planning, prioritization, problem solving and organizational skills.
▪Track record of successfully managing multiple clinical trials concurrently. Used to managing multiple priorities.
▪Demonstrated capability to interpret, discuss and represent trial level data.
▪ Working knowledge of clinical finance principles to manage efficient expenditure to minimize variance between actual and forecasted spend.
▪ Maintain good knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies.