Head of Medical Experts, Therapeutic Dermatology
On-siteZug, Zug, Switzerland
Job Summary
Lead global medical experts and internal/external Medical Experts on Therapeutic Dermatology clinical development programs, securing adherence to quality management systems and regulatory requirements. Plan, allocate resources, and organize activities to meet R&D objectives while preparing regular updates for senior management and regulatory bodies. Design, implement, and execute Clinical Development Plans, providing clinical strategy for protocols, investigator brochures, and submission documents. Serve as lead medical expert interacting with external stakeholders and internal teams to advise investigators and CROs on study execution. Evaluate product benefit-risk profiles, defend medical positions with regulatory authorities, and support clinical data review, safety analysis, and CTD submissions. Develop presentation materials for advisory boards and execute clinical communication strategies.
Required Qualifications
- Medical Degree
- Dermatologist with experience in Therapeutic Dermatology
- Knowledge in clinical development
- Minimum of 10 years of drug development experience in Therapeutic Dermatology
- Minimum of 5 years of demonstrated leadership, management, and accomplishment conducting clinical trials in Therapeutic Dermatology
- Excellent knowledge of international guidelines ICH/GCP
- Basic knowledge of GMP/GDP
- Experience with regulatory submissions and health authority interactions
- Proven ability to interpret and present efficacy and safety data derived from clinical trials in Therapeutic Dermatology
- Demonstrated technical knowledge of methodology of study designs in Therapeutic Dermatology
- Experience in working with and managing CROs and consultant Medical Experts in Therapeutic Dermatology
- Excellent interpersonal and communication skills
- High learning agility
- Fluent oral and written English
- Willingness to travel for internal corporate and external investigator and scientific meetings, both nationally and internationally
- Travel estimated at 20%
- Lift and/or move up to 25 pounds
Desired Qualifications
- Dermatologist with experience in Therapeutic Dermatology and knowledge in clinical development preferred
- Minimum of 5 years of demonstrated leadership, management, and accomplishment conducting clinical trials in Therapeutic Dermatology
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