Senior Clinical Trial Manager

Galderma Research & Development, LLC; Boston (MA); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with employer match

Paid time off

Job summary

Galderma Research & Development, LLC is seeking a Senior Clinical Trial Manager to plan and manage global clinical trials. You will lead cross-functional teams, oversee CROs and external partners, and ensure regulatory compliance throughout development. Travel up to 20% is expected.

The role requires a life sciences degree, 5+ years in clinical research, and proven experience in major markets (US, China). English fluency is essential and you will work within a collaborative, growth-focused

Qualifications

• University degree required in Life Sciences (biology, pharmacology, nursing or health sciences).
• Progressive experience in clinical research/operations (at least 5 years).
• Experience across the full clinical trial process, from protocol development to study reports.
• Experience managing clinical trials in major markets like the US and China.
• Experience supervising CROs and working with external partners.

Responsibilities

• Plan and conduct clinical trials.
• Lead and manage cross-functional Clinical Trial Team to meet timelines, budgets and quality standards.
• Collaborate with Clinical Science Experts for trial design.
• Establish milestones, budgets and timelines with the team and outsourcing manager.
• Manage trial progress and ensure documentation aligns with timelines and regulations.
• Identify risks and develop mitigation plans for program risk.
• Contribute to regulatory submissions and ensure compliance with regulations.
• Provide oversight to Clinical Research Associates and Trial Administrators as needed.
• Manage CROs and FSPs and coordinate with Procurement for outsourcing specs.
• Prepare for regulatory inspections and participate in inspection readiness.

Skills

English fluency

Clinical trial management

CRO supervision

ICH/GCP knowledge

Education

University degree in Life Sciences or related

Job description

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 FSPs.
• Serve as the primary trial contact with the CRO and FSPs.
• 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 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).
• Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally. Travel estimated at 20%.

Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role. This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.

Compensation

The target base salary range for this role is $110,000-$135,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors. In addition to base salary, this role is eligible to participate in an annual short-term incentive program, subject to plan terms and eligibility requirements.

Benefits

• medical, dental, and vision coverage
• a 401(k) plan with employer match
• paid time off
• other benefits, subject to eligibility and applicable plan terms

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

What We Offer

At Galderma, you'll be part of a purpose-driven organization committed to advancing dermatology and improving patient outcomes worldwide. We offer competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.

We are dedicated to building a diverse, inclusive, and innovative workplace.

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. For more information go to www.galderma.com/careers