327752BR
Mar 15, 2022
China

Job Description

6500! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. The NIBR portfolio consists of projects using several therapeutic modalities including small molecules, biologics, gene therapy and cell-based therapies. We collaborate across scientific and organizational boundaries, with a focus on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients.

Purpose:
-Oversees all operational aspects of clinical trials end-to-end including the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations
- Provides line management oversight to 5-8 direct reports

Your key responsibilities:
In this role the candidate with have a dual role of study lead and line manager (about 50/50)

Accountable for all aspects of individually-assigned TCO clinical trials including leading Clinical Trial Team (CTT). Major accountabilities:
· Is a global clinical lead or country; Responsible for the planning, executing & implementation of operational strategy of assigned clinical trial(s); Lead the protocol development process
· Contribute to the development of clinical sections of regulatory documents; develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication.
· 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.
· In collaboration with the medical 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. 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.
· Support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China. Contributes to the global initiatives (e.g., process improvement, training, SOP development, other line function initiatives)

Provides line management oversight to 5-8 direct reports which comprise of CPAs/aCTLs/CTLs. Major accountabilities:
· Assessment of workload for direct reports; Accountable for overall management of direct reports. Supports Clinical Operations Site Head in identifying training needs to foster high level of performance, support career development through quality development plans. Proactively manage performances issues.
· Contributes to the identification of key talent and the hiring process; Contribute to talent and career development of staff through active participation in on-boarding, training and mentoring activities. Expect to serve as faculty member for TCO training programs including lessons learned opportunities
· Ability to escalate issues preventing staff from reaching objectives or completion of tasks; Shares knowledge and insights with colleagues on ways to achieve goals and overcome challenges. Focuses on solutions and not errors. Shows determination to help CTLs get their trials back on track when setbacks have occurred

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role :
• People Leadership Organization Scope
• Scale and Complexity People Challenges
• Advanced degree or equivalent education/degree in life science/healthcare strongly recommended.
• Fluent English (oral and written).
• ≥ 6 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization.

Desirable Requirements:
Advanced degree or equivalent education/degree in life science/healthcare strongly recommended
≥ 6 years technical, operational and managerial experience

Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact,
in this world of digital and technological transformation, we must also ask ourselves this: how can
we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are
brought together in an inspiring environment. Where you’re given opportunities to explore the power of
digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re
surrounded by people who share your determination to tackle the world’s toughest medical
challenges.
Imagine what you could do at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. 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.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish
to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network
here: https://talentnetwork.novartis.com/network
NIBR
Oncology NIBR
China
Shanghai
Research & Development
Full Time
Regular
No
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327752BR

Lead Clinical Trial Leader

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