Head of Clinical Process and Standards

Galderma S.A.; Boston (MA); On-site; USD 200,000 - 265,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) with employer match

Paid time off

Job summary

Galderma S.A. in Boston is seeking a seasoned Head of Clinical Process and Standards to lead global CTAs and oversee critical TMF, SOPs, and training programs. You will align clinical processes with ICH/GCP and regulatory standards while partnering with quality to ensure inspection readiness.

You will drive system maintenance for TMF/CTMS, develop standard documents, and implement scalable training tools, enabling efficient, compliant trial execution across the portfolio.

Qualifications

• 15+ years of progressive experience in clinical operations
• Minimum 5 years in a managerial role in Pharma/Biotech or CRO
• Systemic drug and biologics experience preferred
• Excellent knowledge of ICH/GCP, GMP/GDP
• Strong understanding of the product development process and CTMS/eTMF

Responsibilities

• Lead a global team of CTAs supporting clinical trials
• Oversee TMF inspection readiness for all studies
• Develop and implement strategies for clinical trial operations
• Maintain and improve CTMS and eTMF systems
• Drive process development, training, and standardization across study teams
• Collaborate with quality to ensure inspection readiness and CAPA responsiveness

Skills

Leadership

Clinical Operations

Project Management

CTMS

eTMF

GCP/ICH Knowledge

Regulatory Inspection Readiness

Education

Bachelor’s degree in Life Sciences or related field

Tools

CTMS

eTMF

Job description

## Head of Clinical Process and StandardsApplylocations: Bostontime type: Full timeposted on: Posted 9 Days Agojob requisition id: JR020290Galderma 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 **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****Leadership and Management*** 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 **Process Development/Training Support*** 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. **Clinical Systems*** 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. **Clinical Trial Support*** 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** 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. **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 Don't meet every single requirement? At Galderma, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway! If you are considering employment at Galderma, review our job postings at www.galderma.com/us/careers. Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.