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

Glenmark Pharmaceuticals; Varese; Remoto; EUR 100.000 - 160.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves leading clinical development programs from pre-registration to commercialization, ensuring compliance with regulatory standards, and fostering partnerships with stakeholders. The ideal candidate will have extensive experience in clinical sciences, a strong understanding of regulatory pathways, and exceptional communication skills. If you are passionate about advancing dermatological innovations and thrive in a collaborative environment, this opportunity is perfect for you.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration.
• Trained dermatologist with knowledge of drug development processes.

Mansioni

• Evaluate clinical data for registration strategies.
• Collaborate with cross-functional teams for clinical development.
• Provide medical monitoring for dermatology studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data interpretation

Communication skills

Formazione

MD in Dermatology

Postgraduate medical degree

Descrizione del lavoro

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

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

The Clinical Sciences/Clinical Development Director for dermatology shall be responsible for providing a high level of clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives in various markets. The person shall provide strategic and tactical clinical leadership for successful evaluation and planning of clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration clinical trials, and lifecycle management of dermatology products across markets. Additionally, the person shall review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit between internal and external stakeholders throughout product development and lifecycle stages. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators including EU/USFDA.

Job Responsibilities:

• Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration purposes.
• Collaborate with teams such as Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution, regulatory interactions, etc.
• Provide medical monitoring and supervision of dermatology clinical studies.
• Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to foster scientific understanding and advocacy.
• Support global medical affairs with expertise on licensing and acquisition opportunities for late-stage and marketed dermatology products.
• Plan dissemination of data through publications, presentations at conferences, symposia, and journals.
• Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• MD or equivalent postgraduate medical degree in dermatology with approximately 10-12 years of experience in clinical sciences, regulatory registration dermatology studies, or Phase 1-3 clinical development in pharma/biotech companies.
• Understanding of drug development processes and regulatory pathways in various markets.
• Ability to interpret complex clinical trial data and present findings effectively.
• Experience working in cross-functional teams within a complex matrix organization.
• Proficiency in financial/resource planning and management.
• Excellent communication and presentation skills to meet scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across different geographies.