<p>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.</p> <p>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.</p> <p>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.</p> <p>Based on-site 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.</p> <p>Key Responsibilities:</p> <p>Plan and Conduct Clinical Trials</p> <ul> <li> <p>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.</p> </li><li> <p>Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials.</p> </li><li> <p>Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager.</p> </li><li> <p>Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines.</p> </li><li> <p>Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks.</p> </li><li> <p>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</p> </li><li> <p>As applicable, provide oversight to Clinical Research Associates and Clinical Trial Administrators assigned to the clinical trial</p> </li></ul> <p>Manage Contract Research Organizations (CROs) and Functional Service Providers (FSPs)</p> <ul> <li> <p>Collaborate with Procurement to prepare clinical outsourcing specifications.</p> </li><li> <p>Participate in the selection of the CRO or FSPs.</p> </li><li> <p>Serve as the primary trial contact with the CRO and FSPs.</p> </li></ul> <p>Quality and Process</p> <ul> <li> <p>Ensure that all aspects of the trial are prepared for regulatory inspections at any time.</p> </li><li> <p>Serve as member of the inspection readiness team in preparation of a regulatory inspection.</p> </li><li> <p>Support the preparation for and conduct of investigational site and sponsor health authority inspections, as applicable.</p> </li><li> <p>Contribute to and initiate trial and departmental process improvement initiatives.</p> </li></ul> <p>Key Qualifications:</p> <ul> <li> <p>University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences</p> </li><li> <p>Progressive experience in clinical research/operations (=15 years), including 5 years in a managerial role or equivalent with Pharma/Biotech and/or CRO experience</p> </li><li> <p>Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports</p> </li><li> <p>Experience as manager of clinical trials in major market(s) such as US, China</p> </li><li> <p>Experience in supervising CROs</p> </li><li> <p>Excellent understanding of the drug development process, systemic drug and biologics experience preferred</p> </li><li> <p>Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP</p> </li><li> <p>Excellent knowledge of relevant local regulations</p> </li><li> <p>Fluent in English (written and oral)</p> </li></ul> <p>What we offer in return:</p> <p>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 cross-training.</p> <p>Next Steps:</p> <ul> <li> <p>If your profile is a match, we will invite you for a first virtual conversation with the recruiter.</p> </li><li> <p>The next step is a virtual conversation with the hiring manager</p> </li><li> <p>The final step is a panel conversation with the extended team</p> </li></ul> <p>Our people make a difference:</p> <p>At Galderma, you'll 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.</p> <p>Employer's Rights:</p> <p>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.</p>