Protocol and Clinical Program Excellence Director
Posted 1 day ago by SRG
£570 Per day
Inside
Hybrid
London Area, United Kingdom
Summary: The Protocol & Clinical Program Excellence Director is responsible for providing strategic and operational support to enhance clinical development programs in alignment with the overall strategy. This role involves collaboration with various stakeholders, including the Central Integrated Scientific Review Committee, to ensure high-quality clinical documentation and processes. The position is based in London and operates in a hybrid working model. The director will also contribute to the development of clinical capabilities and digital transformation in clinical trials.
Key Responsibilities:
- Provides scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC).
- Develops harmonized processes, tools, and resources for the C-ISRC process.
- Acts as a delegate to the Head Protocol & Clinical Program Excellence in stakeholder interactions.
- Enhances and simplifies clinical development approaches to improve trial outcomes.
- Engages with the clinical development community to share learnings across therapeutic areas.
- Supports strategic directions for professional clinical development capability building.
- Builds cross-functional collaborations for the transition to digital clinical trials.
Key Skills:
- MD or advanced degree in life sciences/healthcare; PharmD or PhD preferred.
- Over 5 years of experience in clinical research or drug development.
- More than 3 years of experience in conducting clinical trials in a global/matrix environment.
- Excellent interpersonal, negotiation, and conflict resolution skills.
- Strong verbal and written communication skills.
Salary (Rate): £570/day
City: London
Country: United Kingdom
Working Arrangements: hybrid
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
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