摘要
As a Clinical Trial Leader, you will be accountable for all aspects of managing and executing early-phase clinical trials to deliver high-quality data for strategic decision-making and drug registration. You will oversee the planning, implementation, and operational aspects of Phase 1 and clinical pharmacology trials from conception to reporting, ensuring adherence to timelines, budget, and quality standards (ICH/GCP/SOPs and procedures).
This is a hybrid role requiring on-site presence at the Westworks London office three days a week. Please note that we are unable to offer work-permit support for this role.
About the Role
Major Accountabilities:
- Oversight of Outsourced Activities: Focus on Phase I and clinical pharmacology trials, ensuring Clinical Research Organisation (CRO) partners meet timelines and deliverables aligned with project priorities and strategy.
- Team Leadership: Lead and matrix-manage multidisciplinary teams to ensure all trial deliverables are met. Set ambitious goals, promote realistic planning and timelines, and present actionable alternatives to accelerate timelines. Collaborate with line functions to gain input and alignment, managing internal and external stakeholder expectations.
- Study Planning and Set-Up: Lead all aspects of study planning and manage study set-up in collaboration with procurement personnel, team members, and local country office representatives. Interact with CRO partners/sites to ensure smooth study set-up and conduct, review site performance, protocol and quality deviations, and address any issues raised.
- Scientific Review: Prepare, lead, or support the ongoing medical/scientific review of clinical trial data including dose escalation meetings with investigators. Coordinate the real-time availability of quality clinical trial data to provide consolidated information for dose escalation meetings and data review with relevant stakeholders.
Minimum Requirements:
Note: We have the option to hire someone at the Senior Clinical Trial Leader level if this role better matches the applicant's experience and skill set.
- Education: Bachelor's degree in life sciences/healthcare required; advanced degree or equivalent education in life sciences/healthcare preferred (PhD/MD/PharmD/Masters).
- Experience: Approximately 2+ years of experience in clinical trials/development.
- Language: Fluent in English (oral and written).
- Skills: Demonstrates high learning agility, ability to drive collaborations through unpredictable circumstances and high-paced changes, and leadership and influence by creating a positive work environment that inspires and encourages mutual respect.
Why Novartis? Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. http://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: http://talentnetwork.novartis.com/network
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? http://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: http://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: http://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.
