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 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.
Essential Functions
Plan and Conduct Clinical Trials
1. 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.
2. Work closely with the Clinical Science Experts and Clinical Scientist for the design of the clinical trials.
3. Establish project milestones, budget and timelines for the study in partnership with the Clinical Trial Team and outsourcing manager.
4. Manage clinical trial progress and ensure completeness of documentation and data collection in adherence with the project timelines.
5. Proactively identify potential risks and develop & implement action plans to avoid or mitigate program risks.
6. 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
7. 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)
8. Collaborate with Procurement to prepare clinical outsourcing specifications.
9. Participate in the selection of the CRO or FSPs.
10. Serve as the primary trial contact with the CRO and FSPs.
Quality and Process
11. Ensure that all aspects of the trial are prepared for regulatory inspections at any time.
12. Serve as member of the inspection readiness team in preparation of a regulatory inspection.
13. Support the preparation for and conduct of investigational site and sponsor health authority inspections, as applicable.
14. Contribute to and initiate trial and departmental process improvement initiatives.
Minimum Education, Knowledge, Skills, and Abilities
15. University degree required in Life Sciences such as biology, pharmacology, nursing, or health sciences
16. Progressive experience in clinical research/operations (at least 5 years)
17. Experience from all parts of the clinical trial process, from protocol development to the compilation of study reports
18. Experience as manager of clinical trials in major market(s) such as US, China
19. Experience in supervising CROs.
20. Excellent understanding of the drug development process, systemic drug and biologics experience preferred
21. Excellent knowledge of international ICH/GCP guidelines, basic knowledge of GMP/GDP
22. Excellent knowledge of relevant local regulations
23. Fluent in English (written and oral)
Working Conditions & Physical Requirements
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
24. Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
25. Climb stairs or ride elevators.
26. Lift and/or move up to 25 pounds.
27. Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
28. Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
29. Be exposed to outside weather conditions while going in and out of office buildings.
30. Be exposed to moderate noise level usually in warehouse settings.
31. Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
32. Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%.
About the Compensation:
The base salary range for this role is determined based on several factors. These include but are not limited to job accountabilities; skill sets; experience and training; certifications; work location; competitive market rates and other business needs. At Galderma, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on a unique combination of factors for each role. A reasonable estimate of the hiring range for this role is $170,000-$190,000.
In addition to base salary, we provide an opportunity to participate in an annual short-term incentive program that is based on corporate performance with a multiplier focused on individual performance. We offer a competitive and comprehensive benefits program including health insurance, 401(k) plan with employer match, a generous paid time off policy, hybrid work schedules and more.
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 cross-training.
Next Steps
33. If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
34. The next step is a virtual conversation with the hiring manager
35. The final step is a panel conversation with the extended team
Our people make a difference
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.