Protocol & Clinical Program Excellence Director
2 weeks ago
Protocol & Clinical Program Excellence Director
Contract Length 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
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