Protocol & Clinical Program Excellence Director
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Protocol & Clinical Program Excellence Director
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Summary
The Protocol & Clinical Program Excellence Director will provide strategic, scientific planning and operational execution support to the Head Protocol & Clinical Program Excellence to deliver on the CD program excellence goals aligned with the overall CD strategy and vision.
Summary
The Protocol & Clinical Program Excellence Director will provide strategic, scientific planning and operational execution support to the Head Protocol & Clinical Program Excellence to deliver on the CD program excellence goals aligned with the overall CD strategy and vision.
The role will support the scientific and operational activities of CD Central Integrated Scientific Review Committee (C-ISRC) and work closely with Head Protocol & Clinical Program Excellence, C-ISRC Leads, CD(M)Ds and trial teams, as well as cross functional partner functions as needed.
This role is based in the UK / London and in a hybrid working approach
About The Role
* Provides scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC), supporting, as requested, the Head Protocol & Clinical Program Excellence with the review of Clinical Development Plans (CDPs) and Key clinical documents (Study protocols, DMC charters, etc), to maintain high levels of quality and consistency across the therapeutic areas.
* Develops harmonized processes, tools and resources to enable a seamless C-ISRC process
* Supports and acts as delegate to the Head Protocol & Clinical Program Excellence in activities like interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring committees, advisory boards etc.) and internal NVS stakeholders as needed.
* Supports enhancement and simplification of the Novartis clinical development approach (CDP, clinical trial designs, protocol and its review) to improve speed and outcome success of clinical programs.
* Engages the CD(M)Ds and the broader CD community around clinical learnings across therapeutic areas. Supports the CD talent step-up strategy. Supports strategic directions for professional CD capability building.
* Supports the Head Protocol & Clinical Program Excellence to build cross-function collaborations and initiatives leading to a step-wised transition to the futuristic digital clinical trial era.
Education And Minimum Experience
* MD or advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred
* More than 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.
* More than 3 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
* Excellent interpersonal, negotiation, conflict resolution verbal and written communication skills
* Strong skills at influencing without formal authority
* Fluent oral and written English
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
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Research, Analyst, and Information Technology
* Industries
Pharmaceutical Manufacturing
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