Global Head of Clinical Trial Management

Galderma•Boston, MA

4d•Hybrid

About The Position

The Global Head of Clinical Trial Management is a key member of the Clinical Operations team dedicated to achieving and exceeding business objectives through efficient execution, high quality and timely deliverables of all associated aspects of the clinical trial, in compliance with the clinical protocol, Good Clinical Practice guidelines, standard operating procedures and applicable regulatory requirements.

Requirements

University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
Progressive experience in clinical research/operations (≥10 years), including at least 5 years in a managerial role or equivalent with Pharma/Biotech and/or CRO experience
Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
Experience as manager of clinical trials in major market(s) such as US, China
Experience in supervising CROs.
Excellent understanding of the drug development process, systemic drug and biologics experience preferred
Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
Excellent knowledge of relevant local regulations
Fluent in English (written and oral)

Responsibilities

Lead a global team of internal/external Clinical Trial Managers (CTMs) responsible for the conduct of global, clinical trials across development phases and the Galderma pipeline.
Provide operational leadership to the clinical trial team, ensuring trials are conducted efficiently and meet regulatory requirements.
Plan, lead, allocate resources and organise the activities within the group in liaison with the other functional leaders to ensure achievement of set R&D objectives.
Supervise relationships with CROs and other external vendors contracted by Galderma to perform clinical trial activities.
Prepare and present regular updates and reports to senior management, stakeholders, and regulatory bodies on the status of a clinical trial.
Lead the development and improvement of SOPs and working instructions related to Clinical Trial Management.
Develop training standards for Clinical Trial Managers across all indications and locations.
Contribute to the building of high performing teams across all Galderma R&D locations.
Oversee the planning, execution, and reporting of all phases of global clinical trials in compliance with the clinical protocol, Good Clinical Practice, standard operating procedures and applicable regulatory requirements.
Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines.
Accountable for development and management of line budget and oversight of clinical study budgets; verify clinical activities and approve invoices according to the defined budget.
Collaborate with the Clinical Trial Excellence team to identify, select, and manage relationships with clinical sites, investigators and external vendors/partners.
Drive sites and vendors to meet aggressive timelines, on budget, and hold them to account if they fall behind.
Collaborate with the Clinical Supplies Unit to oversee the clinical supply forecast and re-supply.
Foster a culture of inspection readiness within the organization, ensuring the team aims to always maintain a state of readiness.
Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks and make appropriate trade-offs of balancing risks with study deliverables and costs.
Ensure design, execution and report of clinical studies and clinical documentation to regulatory submissions according to plan and in compliance with applicable regulatory requirements, international standards and the company quality system throughout the development life cycle.
May temporarily serve as a CTM providing support as needed or independently managing clinical protocols.