摘要
This role is responsible for driving the strategy, development and execution of Clinical Scientific Excellence in compliance with Novartis processes, ICH GCP and regulatory requirements. The Group Head reports to Head CSE and support Senior Leaders from the business and functions within Global Drug Development (GDD) to help to progress how Novartis innovates, engages and operates.
The Development Units will be a key stakeholder and interactions will primarily focus on CSE support of Clinical Trials. Drives cultural change in the company, direct, oversee and coordinate all activities, deliverables and resources within CSE group and Development unit(s).
The CSE role applies the principles of clinical data review excellence and identifies clinical data insights to ensure data is scientifically plausible and to identify trends, signals and risks associated to trial endpoints and patient safety. The Group Head is expected to act as a leader on any cross-organizational governing body on clinical data review strategies through local and global level initiative.
This role is based in the UK / London and in a hybrid working approach
About the Role
Main Accountabilities but not limited to:
- Selects, recruits, develops, manages, motivates, coaches and appraises the performance of direct reports to ensure high quality performance and support career development through quality development plans across the CSE Team.
- Manages and coordinates the assignment of resources and workload within group or disease area, and ensures sharing of resources between groups in order to meet company objectives and priorities.
- Provides all necessary support to help address and resolve issues. Identifies solutions for remediation, while building team spirit exhibiting the Novartis Values and behaviours
- Leads and supports special projects and initiatives/highlights the need for training programs and supports the establishment of these (technical and professional skills) for CSE group and ensure staff training is conducted and properly documented.
- May act as a Subject Matter Expert for key operational areas influencing Clinical Scientific Expert Group and wider area of Clinical Development
Education & Experience
- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. Master’s, PharmD, MPharm, PhD, MBBS, BDS, MD strongly preferred.
- ≥3 years scientific, strategic and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia, or 5+ years in Clinical Operations/Clinical Scientific role. >5 years experience in team/ matrix management preferred
- In-depth knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. Thorough knowledge of principles of clinical data collection and reporting; ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Experience in Rave and/or OC-RDC is an advantage.
- Intermediate to Advanced knowledge with hands-on experience in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization or similar experience with an academic research institution
- Strong scientific knowledge of assigned therapeutic area(s) is desired (e.g., understanding of basic mechanisms of diseases and associated symptoms, standard of care/treatment, scientific endpoints & clinical outcomes). Show capability to interpret, discuss and represent trial or program level data.
- Superior people management skills with demonstrated positive leadership, innovative, and collaborative behaviours
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
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
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
Universal Hierarchy Node
London (The Westworks)
GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
Research & Development
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Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.