Protocol & 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 will lead strategic and operational support for clinical development programs, ensuring alignment with overall goals and vision. This role involves collaboration with various stakeholders, including the Central Integrated Scientific Review Committee, to enhance clinical trial processes and outcomes. The position is based in London and operates on a hybrid working model. The ideal candidate will have significant experience in clinical research and drug development, particularly in a global pharmaceutical context.
Key Responsibilities:
- Provide scientific and operational support to the Central Integrated Scientific Review Committee (C-ISRC).
- Assist the Head Protocol & Clinical Program Excellence with the review of Clinical Development Plans (CDPs) and key clinical documents.
- Develop harmonized processes, tools, and resources for the C-ISRC process.
- Act as a delegate for the Head Protocol & Clinical Program Excellence in interactions with external and internal stakeholders.
- Enhance and simplify clinical development approaches to improve trial success rates.
- Engage with clinical development teams to share learnings across therapeutic areas.
- Support the clinical development talent strategy and capability building initiatives.
- Facilitate cross-functional collaborations to 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 pharmaceutical environment.
- Excellent interpersonal, negotiation, and conflict resolution skills.
- Strong verbal and written communication skills in English.
- Ability to influence without formal authority.
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
Strong skills at influencing without formal authority
Fluent oral and written English