Head of Clinical Process and Standards

Galderma Research & Development, LLC; Boston (MA); On-site; USD 200,000 - 265,000; Full time

Job summary

Galderma Research & Development, LLC in the United States seeks a Head of Clinical Process and Standards to oversee TMF, clinical systems, and SOP governance within Clinical Operations, ensuring GCP compliance and inspection readiness.

You will lead a global team of CTAs, drive process improvements, and collaborate with QA, IT, and portfolio leaders to support regulatory inspections and digital transformation.

Qualifications

• Bachelor's degree required in Life Sciences or related field.
• Minimum 15 years progressive clinical operations experience, with at least 5 years in a managerial role.
• Strong knowledge of ICH/GCP and applicable local regulations.

Responsibilities

• Lead a global team of CTAs responsible for operational tasks supporting clinical trials.
• Develop and implement strategies for clinical trial operations to meet organizational goals.
• Oversee maintenance and improvements of CTMS and other clinical systems.
• Ensure TMF remains inspection ready and compliant with GCP.
• Collaborate with IT to translate departmental needs into timely system improvements.
• Develop and oversee training content in PATH and study-level training tools.
• Establish and maintain a clinical systems roadmap aligned with portfolio growth.
• Foster a culture of inspection readiness and continuous process optimization.

Skills

Leadership

ICH/GCP knowledge

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

eTMF

Job description

Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing and rewarding people for the contribution they make - working here isn't like anywhere else. At Galderma, we actively give our teams reasons to believe in our 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 Head of Clinical Process and Standards is a pivotal role in the Clinical Operations team working closely with the Clinical Operations Leadership Team. This position involves the oversight of key study components including the trial master file, clinical systems, process improvement initiatives, and clinical controlled documentation (e.g., Standard Operating Procedures (SOPs), work instructions, forms). This role will also work closely with quality to ensure inspection readiness at all times and to share best practices across study teams. This role serves as the infrastructure to ensure quality and standardization in the execution of trials, including inspection readiness, and in line with Good Clinical Practice and regulatory standards.

Key Responsibilities

• Member of the Clinical Operations Leadership Team
• Lead a global team of internal/external Clinical Trial Administrators (CTAs) responsible for managing operational tasks in support of clinical trials.
• Develop and implement strategies for clinical trial operations to meet organizational goals.
• Oversee system maintenance and improvements for the Clinical Trial Management System and other clinical systems.
• Interact with IT to determine the departmental needs and ensure timely implementation
• Ensure Trial Master File (TMF) remains inspection ready at all times, for both internally and externally managed studies
• Develop and continuously improve Galderma clinical controlled documents (i.e., SOPs, Work Instructions, Forms) to ensure high quality execution and compliance with GCP and inspection readiness.
• Develop and oversee training compliance and content in the Galderma Training system (PATH)
• Develop and improve study-level training tools/systems to support the study teams in training reconciliation and tracking.
• Develop and implement clinical processes and tools to create consistency, enhance compliance and efficiency, while maintaining operational excellence and quality.
• Develop and improve training and process materials through the identification of trends and lessons learned from study/program teams and internal/external inspections.
• Serve as the BPO (Business Process Owner) for CTMS, eTMF, and other potential future clinical systems.
• Establish and maintain a clinical systems roadmap aligned with portfolio growth and digital transformation objectives.
• Ensure the appropriate risk and change management processes are developed and implemented to support new and updated system implementations.
• Oversee eTMF system migration, updates, and inspection readiness, alongside the TMF manager.
• Solicit feedback from development teams on opportunities for improvement and process optimization.
• Work with members on the Clinical Operations Team to build an onboarding/training program for clinical operation roles.
• Foster a culture of inspection readiness within the organization, ensuring the team aims to always maintain a state of readiness.
• Serve as a conduit between clinical operations and quality to share best practices and industry and inspection trends
• Serve as member of the inspection readiness team, including regulatory inspection preparation, Corrective Actions Preventative Actions (CAPA) response drafting/review, and extrapolation of lessons learned outputs

Qualifications

• Bachelor’s degree in Life Sciences or a related field, required
• Minimum of 15 years progressive experience in clinical operations including 5 years in a managerial role or equivalent with Pharma/Biotech and/or CRO experience
• Systemic drug and biologics experience preferred.
• Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP
• Excellent knowledge of relevant local regulations
• Excellent understanding of the product development process
• Excellent understanding of Clinical Trial Management

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 $200,000-$265,000 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 and long-term incentive program, subject to plan terms and eligibility requirements.

Benefits Galderma offers a competitive and comprehensive benefits program, including medical, dental, and vision coverage, a 401(k) plan with employer match, paid time off, and 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

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.

Don’t meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace.