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

Glenmark Pharmaceuticals; Pordenone; Remoto; EUR 90.000 - 160.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Clinical Development Director specializing in dermatology. This pivotal role involves leading clinical strategies from pre-registration to commercialization, ensuring regulatory compliance, and fostering partnerships with key stakeholders. Ideal candidates will have a strong dermatology background, extensive experience in clinical development, and the ability to interpret complex data. Join a forward-thinking organization that values innovation and collaboration, and make a significant impact in the dermatology field by guiding the development of groundbreaking products.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Trained dermatologists with regulatory registration study experience.

Mansioni

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

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data interpretation

Communication skills

Formazione

Medical degree (MD or equivalent)

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 the pre-registration stage to commercialization of innovative products. The role aims to achieve Glenmark’s objectives across various markets. Responsibilities include providing strategic and tactical clinical leadership to support the evaluation, planning, protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products. The person will review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit between internal and external stakeholders throughout the product lifecycle. Candidates should be trained dermatologists with experience in clinical sciences/clinical development for registration assets and familiarity with regulators such as EU/USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration.
2. Collaborate with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution, regulatory interactions, etc.
3. Provide 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. Support global medical affairs with expertise on licensing and acquisition opportunities for late-stage and marketed products.
6. Plan dissemination of data through publications, presentations at conferences, symposia, and journals.
7. Ensure compliance with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

1. Medical degree (MD or equivalent) in dermatology, with 10-12 years of experience in clinical sciences, regulatory registration studies, or clinical development in pharma/biotech industries.
2. Understanding of drug development processes and regulatory pathways for dermatology in various markets.
3. Ability to interpret complex clinical trial data and work within cross-functional, matrix organizations.
4. Experience in financial/resource planning and management.
5. Excellent presentation and communication skills, capable of coordinating across global teams and stakeholders.