Job Description

Protocol & Clinical Program Excellence Director

Contract Length - 12 -18 months

Rate - £570/day via Umbrella only

Hybrid from London office

Job Description 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

Job Description

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 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

• 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