Director/ Sr Director/ Executive Director- Clinical Development (Dermatology)

Glenmark Pharmaceuticals; Arezzo; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology to lead innovative product development from pre-registration to commercialization. This pivotal role requires strategic oversight in clinical evaluation, regulatory interactions, and lifecycle management of dermatology products. The ideal candidate will possess a medical degree and extensive experience in clinical sciences, with a strong understanding of regulatory pathways. Join a dynamic team that values collaboration and scientific excellence, and make a significant impact on the future of dermatological care across global markets.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Expertise in drug development and regulatory pathways in dermatology.

Mansioni

• Evaluate clinical data to inform development strategies for registration.
• Collaborate across teams for planning, protocol development, and execution.
• Oversee medical monitoring of dermatology clinical studies.

Conoscenze

Clinical Development

Dermatology Expertise

Regulatory Knowledge

Data Interpretation

Cross-functional Collaboration

Communication Skills

Formazione

MD or equivalent postgraduate medical degree

Descrizione del lavoro

Director/ Sr Director/ Executive Director- Clinical Development (Dermatology)

Please Note: Incumbent can be based anywhere in Europe or the US.

The Clinical Sciences/Clinical Development Director for dermatology shall provide expert clinical leadership in Dermatology, overseeing the development from pre-registration to commercialization of innovative products to meet Glenmark’s objectives across various markets. This role involves strategic and tactical leadership in clinical evaluation, planning, protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products globally. The person will review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit between internal teams and external stakeholders throughout the product lifecycle. The ideal candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators like the EU and USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration.
2. Collaborate with Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Medical Affairs, and Intellectual Property teams for planning, protocol development, execution, and regulatory interactions.
3. Oversee medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to foster scientific understanding and advocacy.
5. Provide medical/scientific expertise for due diligence on licensing and acquisition of new products, including late-stage and marketed assets.
6. Plan and support dissemination of data through publications, conferences, symposia, and journals.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• MD or equivalent postgraduate medical degree in dermatology.
• Approximately 10-12 years of experience in clinical sciences, regulatory studies, or clinical development in pharma/biotech, including understanding of drug development and regulatory pathways in dermatology.
• Ability to interpret complex clinical data and work effectively in cross-functional, matrix organizations.
• Experience in financial/resource planning and management.
• Excellent communication and presentation skills, with the ability to coordinate across geographies and teams.