Head of Medical Experts Ax
- Galderma Prod Canada Inc.
- Dallas
- 9mo ago
- Full-Time
- On-site
Whether it's the unique breadth of our integrated offering that covers Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology products; or our commitment to recognizing 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.
Job Description:
Head of Medical Experts Ax positions offered by Galderma Research and Development, LLC (Dallas, Texas). Provide direct leadership and expertise to the company’s clinical development programs conducted for Aesthetics projects. Ensure that clinical developments are conducted in accordance with Galderma’s 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.