Senior Clinical Trial Manager

Galderma is the emerging pureplay dermatology category leader present in approximately 90 countries. We deliver an innovative sciencebased portfolio of premium flagship brands and services that span the full spectrum of the fastgrowing 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 bodys 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.

Based in our Boston office 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 crossfunctional 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 Scientist 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 FSPs.

• Serve as the primary trial contact with the CRO and FSPs.

Quality 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.

Key Qualifications:

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

• Progressive experience in clinical research/operations 15 years) including 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)

What we offer in return:

You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits including a competitive wage with shift differential annual bonus opportunities and career advancement and crosstraining.

Next Steps:

• If your profile is a match we will invite you for a first virtual conversation with the recruiter.

• The next step is a virtual conversation with the hiring manager

• The final step is a panel conversation with the extended team

Our people make a difference:

At Galderma youll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism collaboration and a friendly supportive ethos is the perfect environment for people to thrive and excel in what they do.

Employers Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract and either you or the employer may terminate employment at any time for any reason. In addition reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.