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Medical Expert Dermatology
hace 4 meses
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**:
Reporting to the Head of Medical Expertise, the Medical Expert Dermatology at Galderma is responsible for providing medical input, leadership, and expertise to global clinical development programs.
- Responsibilities:
- Works as part of a diverse, global team accountable for the design, implementation, execution, and submission/approval of Clinical Development Plans to support conduct of global clinical studies to meet regulatory requirements and budget targets
- Provides medical strategy (e.g. medical rationale, objectives, endpoints) to clinical study outlines, protocols, investigator brochures, briefing packages, CTDs, draft labels, and other documents
- Serves as disease area scientific and medical expert interacting with external stakeholders (e.g., regulatory authorities, CROs, key opinion leaders, advisory boards, patient advocacy groups), and internal stakeholders (e.g., Research, Global Medical Affairs, Marketing, HE&OR)
- Develops presentation materials for advisory boards, investigator meetings, protocol training meetings or other events as required
- Supports ongoing review of clinical trial safety data, analysis, and interpretation in collaboration with global development team members
- Provides medical input in development of TPPs and other relevant documents
- Advises investigators and/or CROs on medically relevant topics emerging during study implementation and conduct
- Supports Clinical Development team in preparation of study documents and clinical data review
- In collaboration with Global Safety Team, evaluates the drug benefit-risk profile, including all aspects relevant to patients, as well as external stakeholders (e.g., health authorities)
- Defends medical positions at meetings with regulatory authorities or other interested parties
- Provides input, review and takes medical lead in preparation of the clinical CTD submission modules
- Addresses medical Q&A at all levels from protocol design to implementation of the study, interpretation of study outcomes and after submission of study results to regulatory authorities and other stakeholders
- Plans and executes publication and clinical communication strategy in collaboration with Global Teams
- Requirements:
- Medical Degree, ideally Dermatologist with knowledge in clinical development
- Experience in Medical Aesthetics is a plus
- Minimum of 2 years of drug development experience
- Minimum of 2 years of demonstrated leadership, management, and accomplishment conducting clinical trials
- Proven ability to interpret and present efficacy and safety data derived from clinical trials
- Experience with regulatory submissions and health authority interactions
- Medical and operational expertise in relevant therapeutic areas
- Demonstrated technical knowledge of methodology of study designs
- Experience in developing systemic medicines and/or biologics
- Experience in working with and managing CROs
- Excellent interpersonal and communication skills with high learning agility
- Ability to navigate in a global, international and matrix organization
- Fluent oral and written English
