Clinical Scientist
vor 14 Stunden
With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology.
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 to promote their personal growth all the 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 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 unparalleled, direct impact.
**Job Description**:
**Job Description**:
As our new Clinical Scientist, you will participate in creating the clinical strategy, design of clinical trials as well as creating documents supporting the scientific aspects of the clinical study and contributing to the clinical study report.
Job Responsibilities
- Assist with organizing, managing and conducting Scientific Advisory Boards and KOL reviews
- Develop, research and maintain current and future competitive clinical landscape(s)
- Identify clinical thought leaders within the appropriate therapeutic area to establish relationships and provide scientific outreach within the dermatological specialty community
- Support the scientific aspects of the clinical study, review data trends through risk based monitoring tool
- Coordinate study design and Protocol development with team members to address scientific questions
- Own scientific aspect/rationale of the protocol (i.e. methods, scales, labs, etc.) and contribute to clinical section of development plan and/or protocol(s) in collaboration with other clinical study team members
- Coordinate with team members to address scientific questions related to planned or ongoing clinical trials, in liaison with relevant staff at CRO(s) and vendors as applicable
- Contribute to the selection of vendors, countries and trial investigators
- Support the development of the Clinical Study Report (CSR), in collaboration with the scientific writer or others
- Contribute to the preparation of regulatory documentation (Briefing Packages, Investigator's brochures, IND/IMPD, labelling documents etc.), and answer to questions from Health Authorities during the review process etc.
- Prepare and review SOPs, and contribute to process improvement initiatives, as deemed appropriate
Minimum Requirements
- 4-7 years of relevant experience in clinical research and development in the pharmaceutical industry and/or in a Contract Research Organization (CRO)
- Experience in the scientific aspects of design and conduct of large and/or complex phase 2/3 clinical trials is preferred
- Fluency with GCP and ICH guidelines
- Bachelor’s degree in Life Sciences, Engineering or related field (Master’s degree, PhD or Medical Doctor, preferred)
- Experience with risk-monitoring systems preferred
- Proven experience in supporting development of systemic agents (large or small molecules)
- Fluent in English (written and oral)
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