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About the Role

Galderma is a leading dermatology company dedicated to advancing skin health. We seek individuals who are results-oriented, eager to learn, and possess a positive attitude, combining initiative with teamwork and collaboration. Passion for making a meaningful impact on consumers, patients, and healthcare professionals is essential. We aim to empower employees and foster personal growth while meeting business needs.

Responsibilities

Provide scientific input to ensure clinical development activities align with regulatory guidance, scientific rationale, and the competitive landscape.
Conduct and/or oversee literature searches to support clinical development strategy, study design, endpoint selection, and data interpretation.
Lead the development of clinical study designs (Phase I-III) in alignment with the overall development strategy.
Manage the development of study protocols, amendments, and Clinical Study Reports (CSRs), ensuring scientific accuracy and consistency.
Ensure study endpoints, eligibility criteria, and assessments are clinically meaningful and scientifically appropriate.
Provide scientific direction and oversight to Medical Writers for clinical and regulatory documents.
Lead the development of the Master ICF and review country- and site-specific ICFs for alignment with master and local regulatory requirements.
Perform Quality Control (QC) to ensure document consistency, accuracy, and formatting.
Act as a key point of contact during study execution, providing protocol-related guidance to Clinical Operations and study teams.
Ensure appropriate filing of authored clinical documents in the Trial Master File (TMF) per company procedures.
Collaborate with Medical Experts, Biostatisticians, Clinical Operations, Safety, Regulatory Affairs, and other stakeholders for integrated study delivery.
Review and interpret clinical data and analyses in collaboration with the Study Team.
Support the preparation of internal data review materials, such as IDMC charters and presentations.
Contribute to, and where appropriate author, clinical sections of regulatory documents, including IND/CTA submissions, Investigator’s Brochures (IBs), CSRs, briefing documents, and responses to health authority questions.
Manage the annual update of the Investigator’s Brochure (IB) in collaboration with cross-functional stakeholders.
Contribute to the development and maintenance of departmental SOPs, clinical document templates (e.g., protocol, IB, CSR), and writing guidelines.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related field required; advanced degree (Master’s, PhD, or MD) preferred.
Clinical or biomedical background relevant to drug development preferred.
Typically, 5–10 years of experience in clinical research or clinical development within the pharmaceutical, biotech, or CRO environment.
Hands-on experience contributing to clinical study design, conduct, and documentation (e.g., protocols, ICFs, IBs, CSRs).
Experience working in cross-functional study teams, in close collaboration with Medical Experts and Biostatisticians.
Practical understanding of clinical data review and interpretation during study conduct.
Experience overseeing or collaborating with Medical Writers and external vendors preferred.
Strong knowledge of ICH-GCP and clinical development regulations.
Solid understanding of the clinical development lifecycle and regulatory documentation requirements.
Experience with TMF requirements and document lifecycle management.
Familiarity with governance activities such as IDMC participation and interim data review is an advantage.
Strong scientific judgment and ability to critically evaluate clinical data and study designs.
Excellent written and verbal communication skills, with the ability to convey complex scientific concepts clearly.
High attention to detail, quality, and consistency in clinical documentation.
Ability to manage multiple deliverables in a matrixed, cross-functional environment.
Proactive, collaborative, and solution-oriented mindset.

Skills

Clinical Development
Study Design
Study Conduct
Literature Searches
Protocol Development
Clinical Study Reports (CSRs)
Informed Consent Forms (ICFs)
Investigator's Brochure (IB)
Regulatory Submissions (IND/CTA)
ICH-GCP
TMF Management
Data Interpretation
Cross-functional Collaboration
Medical Writing Oversight
Vendor Management

Location

90 countries

Work Type

Full-time

Experience Level

5-10 years

Education Level

Bachelor's degree in Life Sciences, Engineering, or related field
Advanced degree (Master's, PhD, or MD) preferred

About the Company

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.
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.
At Galderma we’re unique and we embrace difference.
Whether it’s the unique breadth of our integrated offering that covers Aesthetics, Consumer, and Prescription products; or our commitment to recognising 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.

Equal Opportunity

Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma we’re unique and we embrace difference.
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.