摘要
About the Role
Major accountabilities:
- Study Leader and/or Clinical Scientist for predominantly low complexity, global studies and may provide additional Clinical Sciences support to high complexity, global studies.
- Lead or support the clinical protocol development process in collaboration 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.
- 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.
- Collaborate with key cross functional partners to identify and select strategic and high performing sites to ensure recruitment commitments are met.
- 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.
- Partner with line functions to gain input and alignment and manages internal and external stakeholder expectations.
- 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.
- Prepare, lead or support 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.
Minimum Requirements:
- 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
- Fluent English (oral and written)
- 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 leadership and influence by creating a positive work environment by inspiring and encouraging mutual respect.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity & Inclusion: The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
