Head of Medical Experts Ax

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.

Job Description:

Head of Medical Experts Ax positions offered by Galderma Research and Development LLC (Dallas Texas). Provide direct leadership and expertise to the companys clinical development programs conducted for Aesthetics projects. Ensure that clinical developments are conducted in accordance with Galdermas quality systems international standards and regulatory requirements. Design execute and conduct clinical assessments of all Galderma Aesthetics projects. Support ongoing reviews of clinical trial safety data analysis and interpretation in collaboration with global development teams and provide medical input in development of TPPs and other relevant documents. Advise investigators and CROs on medically relevant topics emerging during study implementation and conduct. Advocate for the benefits and necessity of company products. Address medical Q&As at all levels from protocol design implementation interpretation and outcomes of the study. Collaborate with the Global Safety team to evaluate the aesthetics products benefit-risk profile including all aspects relevant to patients as well as external stakeholders. Provide input review and takes to the medical lead in preparation of clinical CTD submission modules. Plan and execute publication and clinical communication strategy in collaboration with Global Teams. Develop presentation materials for advisory boards investigator meetings protocol trainings or other clinical events as required. Defend medical positions at meeting with regulatory authorities or other interested parties. Manage direct reports from his team to assure necessary performance as well as provide coaching and development support to further develop talent profiles.

Minimum Requirements:

Requires an MD degree (or foreign equivalent) and 5 years of experience as a Medical Expert or similar role in the pharmaceutical industry. Must have education training or experience in each of the following: development of study designs and design input requirements; preparation of early-stage development projects for clinical studies including clinical trial outlines protocols device monitoring or similar; participation and discussion with health authorities such as the FDA or similar; medical clinical evaluation of internal and external innovation products; and preparation of scientific presentation documents for internal committees. Experience may be gained concurrently.