Contribute to building high-performing teams across Galderma R&D locations. * Oversee planning, execution, and reporting of all phases of global clinical trials in compliance with protocol, GCP, SOPs ...
Galderma Research & Development
9 jobs near Columbus, OH
Contribute to building high-performing teams across Galderma R&D locations. * Oversee planning, execution, and reporting of all phases of global clinical trials in compliance with protocol, GCP, SOPs ...
Global Head of Therapeutic Dermatology Regulatory Strategy
Boston, MA · On-site
$163K - $215K/yr
Lifecycle activities of approved portfolio: maintenance of licenses, coordination with R&D, Global ... Galderma offers a competitive and comprehensive benefits program, including medical, dental, and ...
Global Head of Therapeutic Dermatology Regulatory Strategy
Boston, MA · On-site
$163K - $215K/yr
Lifecycle activities of approved portfolio: maintenance of licenses, coordination with R&D, Global ... Galderma offers a competitive and comprehensive benefits program, including medical, dental, and ...
NY · On-site
$147K - $195K/yr
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 ... Provides oversight and critical input to Global R&D colleagues to assist the creation and ...
NY · On-site
$147K - $195K/yr
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 ... Provides oversight and critical input to Global R&D colleagues to assist the creation and ...
To deliver this investment, Galderma is seeking an experienced Senior Director, U.S. Capital Project - Injectable Aesthetics to provide end-to-end leadership of the project from concept development ...
To deliver this investment, Galderma is seeking an experienced Senior Director, U.S. Capital Project - Injectable Aesthetics to provide end-to-end leadership of the project from concept development ...
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading ... As the R&D lead for innovation, the role is accountable for advancing brand and platform innovation ...
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading ... As the R&D lead for innovation, the role is accountable for advancing brand and platform innovation ...
Senior Clinical Trial Manager
Boston, MA · On-site
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 ... development life cycle. * As applicable, provide oversight to Clinical Research Associates and ...
Senior Clinical Trial Manager
Boston, MA · On-site
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 ... development life cycle. * As applicable, provide oversight to Clinical Research Associates and ...
Head of Clinical Process and Standards
Boston, MA · On-site
$86K - $118K/yr
... development, and collaboration in an inclusive and innovative environment. Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative ...
Head of Clinical Process and Standards
Boston, MA · On-site
$86K - $118K/yr
... development, and collaboration in an inclusive and innovative environment. Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative ...
Director, Head of Global Nemluvio Regulatory Strategy
Boston, MA · On-site
$200K - $265K/yr
... development, and collaboration in an inclusive and innovative environment. At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. For more information go to www ...
Director, Head of Global Nemluvio Regulatory Strategy
Boston, MA · On-site
$200K - $265K/yr
... development, and collaboration in an inclusive and innovative environment. At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. For more information go to www ...
Senior Program Manager, Therapeutic Dermatology
Boston, MA · On-site
$126K - $126K/yr
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading ... Drug Development knowledge with a good understanding of other functions relevant to the position ...
Senior Program Manager, Therapeutic Dermatology
Boston, MA · On-site
$126K - $126K/yr
At Galderma, we actively give our teams reasons to believe in our ambition to become the leading ... Drug Development knowledge with a good understanding of other functions relevant to the position ...
Global Head of Clinical Trial Management
Boston, MA • On-site
Other
Re-posted 7 days ago
Key responsibilities
Lead and oversee the Clinical Trial Management group, including internal and external Clinical Trial Managers, to ensure the efficient execution of global clinical trials.
Manage relationships with CROs and external vendors, ensuring trial activities are completed on time, within budget, and in compliance with regulatory and quality standards.
Oversee planning, execution, and reporting of all phases of global clinical trials, ensuring documentation and data collection meet project timelines and regulatory requirements.
Job description
Galderma seeks the Global Head of Clinical Trial Management, a key member of the Clinical Operations team. The role is dedicated to achieving and exceeding business objectives through efficient execution, high quality, and timely deliverables of all aspects of the clinical trial in compliance with the clinical protocol, Good Clinical Practice guidelines, standard operating procedures and applicable regulatory requirements.
Responsibilities- Provide leadership to the Clinical Trial Management group, leading a global team of internal/external Clinical Trial Managers (CTMs) for global trials across development phases and the Galderma pipeline.
- Plan, lead, allocate resources, and organize activities within the group in liaison with other functional leaders to achieve R&D objectives.
- Supervise relationships with CROs and other external vendors contracted to perform clinical trial activities.
- Prepare and present regular updates and reports to senior management, stakeholders, and regulatory bodies on trial status.
- Lead development and improvement of SOPs and working instructions related to Clinical Trial Management.
- Develop training standards for Clinical Trial Managers across indications and locations.
- Contribute to building high-performing teams across Galderma R&D locations.
- Oversee planning, execution, and reporting of all phases of global clinical trials in compliance with protocol, GCP, SOPs, and regulatory requirements.
- Manage trial progress and ensure documentation and data collection meet project timelines.
- Accountable for development and management of line budgets and oversight of clinical study budgets; verify activities and approve invoices per 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 behind schedule.
- Collaborate with the Clinical Supplies Unit to oversee the clinical supply forecast and re-supply.
- Foster a culture of inspection readiness within the organization.
- Identify risks and develop action plans to mitigate program risks, balancing risks with study deliverables and costs.
- Ensure design, execution, and reporting of clinical studies and documentation for regulatory submissions in compliance with applicable requirements and company quality systems.
- May temporarily serve as a CTM providing support as needed or independently managing clinical protocols.
- University degree in Life Sciences (biology, pharmacology, nursing, or health sciences) or equivalent.
- 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 across all parts of the clinical trial process, from protocol development to study report compilation.
- Experience as a manager of clinical trials in major markets (e.g., US, China).
- Experience 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).
The work environment and physical requirements described here are representative of essential functions; reasonable accommodations may be made for individuals with disabilities. Duties may include standing, walking, sitting, climbing, reaching, lifting up to 25 pounds, vision requirements, keyboard use, and travel. Travel estimated at 20%.
Disclaimers and Additional InformationPay transparency information is provided where applicable. This job description does not constitute an employment contract, and Galderma reserves the right to revise the description at any time. All legitimate communications from HR will come from official company email domains, and the company will not request payment or sensitive data during recruitment. Position is commensurate with experience. For compensation context, the base salary range is provided where posted.