Senior Clinical Trial Manager

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals.

Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future.

Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

The Opportunity The Senior Clinical Trial Manager (CTM) plans and manages overall activities for assigned global clinical trial(s). This includes timelines, budgets, resources, investigational sites, vendors and key deliverables. This position ensures compliance with SOPs, regulatory requirements and ICH/GCP guidelines and aligns with company strategies and goals. The Senior CTM may lead other CTMs in the organization depending on the scope of the clinical trial.

Key Responsibilities Plan and Conduct Clinical Trials Lead and manage cross-functional Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices

Work closely with the Clinical Science Experts and Clinical Scientists for the design of the clinical trials

Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager

Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines

Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks

Contribute to the reporting 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

As applicable, provide oversight to Clinical Research Associates and Clinical Trial Administrators assigned to the clinical trial

Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)
Collaborate with Procurement to prepare clinical outsourcing specifications

Participate in the selection of the CRO or FSPsServe as the primary trial contact with the CRO and FSPsQuality and Process Ensure that all aspects of the trial are prepared for regulatory inspections at any time Serve as member of the inspection readiness team in preparation of a regulatory inspection

Support the preparation for and conduct of investigational site and sponsor health authority inspections, as applicable

Contribute to and initiate trial and departmental process improvement initiatives

Qualifications

University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences

Progressive experience in clinical research/operations (at least 5 years)
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 CROsExcellent 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)
Willingness to travel for internal corporate and external…