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

Infovista; Bergamo; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Sciences Director for Dermatology to lead high-level clinical expertise from pre-registration to commercialization. This pivotal role involves strategic leadership in clinical development programs, ensuring compliance with regulatory standards, and fostering partnerships with dermatology stakeholders. The ideal candidate will possess a medical degree and significant experience in clinical development within pharmaceutical or biopharmaceutical companies. Join this innovative firm to make a significant impact in the dermatology field and contribute to the success of groundbreaking products.

Competenze

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

Mansioni

• Evaluate clinical data to develop strategies for registration.
• Collaborate with teams for protocol development and regulatory interactions.
• Plan and oversee publication of data at conferences.

Conoscenze

Dermatology expertise

Clinical development

Regulatory interactions

Data evaluation

Cross-functional collaboration

Financial planning

Presentation 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 the US.

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

Job Responsibilities:

• Critically evaluate clinical data of investigational products and similar drugs to develop clinical development strategies for registration purposes.
• Collaborate with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution support, and regulatory interactions.
• 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 in due diligence for licensing and acquisition of new products.
• Plan and oversee publication and presentation of data at international conferences, symposia, and journals.
• Ensure compliance with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• Medical degree (MD or equivalent) in dermatology with approximately 10-12 years of experience in clinical sciences, regulatory registration studies, or Phase 1-3 clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products across markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional teams within a complex matrix organization.
• Financial and resource planning skills.
• Excellent presentation and communication skills, with the ability to meet scientific and commercial needs.
• Proven ability to coordinate with multiple stakeholders across geographies.