Sr Clinical Scientist

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 bodys 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.

At Galderma were unique and we embrace difference.

Whether its 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 isnt 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.

Key Responsibilities

Clinical Development Study Design & Conduct

• Provide scientific input to ensure clinical development activities are aligned with regulatory guidance scientific rationale and the evolving competitive landscape.
• Conduct and/or oversee targeted literature searches to support clinical development strategy study design decisions endpoint selection and interpretation of emerging data.
• Lead the development of clinical study designs (Phase IIII as applicable) in alignment with the overall development strategy.
• Manage the development of study protocols protocol amendments and clinical study reports (CSRs) ensuring scientific accuracy and consistency.
• Ensure that study endpoints eligibility criteria and assessments are clinically meaningful and scientifically appropriate in collaboration with relevant subject matter experts.
• Provide scientific direction and oversight to contractor Medical Writers involved in the development of clinical and regulatory documents.
• Lead the development of the Master ICF and review country and sitespecific ICFs to ensure alignment with the master and local regulatory and ethics requirements.
• Perform QC to ensure document consistency accuracy and formatting.
• Act as a key point of contact during study execution providing protocolrelated guidance and clarification to Clinical Operations and study teams.
• Ensure appropriate filing of authored clinical documents in the TMF in accordance with company procedures.
• Work closely with Medical Experts Biostatisticians Clinical Operations Safety Regulatory Affairs and other stakeholders to ensure integrated study delivery.

Data Interpretation & Scientific Contribution

• Review and interpret clinical data and analyses in collaboration with the Study Team.
• Support the preparation of internal data review materials e.g. IDMC charters and presentations.

Regulatory & Clinical Documentation

• Contribute to and where appropriate author clinical sections of regulatory documents including IND/CTA submissions Investigators Brochures (IBs) CSRs briefing documents and responses to health authority questions.
• Manage the annual update of the Investigators Brochure (IB) in collaboration with crossfunctional stakeholders.

SOP & Template Development

• Contribute to the development and maintenance of departmental SOPs clinical document templates (e.g. protocol IB CSR) and writing guidelines ensuring alignment with operational needs and regulatory requirements.

Skills & Qualifications

Education

• Bachelors degree in Life Sciences Engineering or a related field required; advanced degree (Masters PhD or MD) preferred.
• Clinical or biomedical background relevant to drug development preferred.

Experience

• Typically 510 years of experience in clinical research or clinical development within the pharmaceutical biotech or CRO environment.
• Handson experience contributing to clinical study design conduct and documentation (e.g. protocols ICFs IBs CSRs).
• Experience working in crossfunctional 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.

Technical & Regulatory Skills

• Strong knowledge of ICHGCP 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.

Core Competencies

• 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 crossfunctional environment.
• Proactive collaborative and solutionoriented mindset.

Next Steps

• If your application is successful and 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

Our people make a difference

At Galderma youll 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.

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Required Experience:

Senior IC

Employment Type : Full-Time
Experience: years
Vacancy: 1