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 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