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

Glenmark Pharmaceuticals; Catania; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves providing strategic clinical leadership to guide innovative products from pre-registration to commercialization. The successful candidate will leverage their extensive clinical expertise and regulatory knowledge to oversee product development and lifecycle management while collaborating with internal and external stakeholders. This is an exciting opportunity to make a significant impact in the dermatology field, ensuring compliance with high standards and contributing to the advancement of cutting-edge therapies.

Competenze

• 10-12 years of experience in clinical sciences and regulatory studies.
• Trained dermatologist with expertise in product lifecycle management.

Mansioni

• Evaluate clinical data to inform development strategies.
• Collaborate with cross-functional teams for clinical execution.
• Provide medical expertise for licensing and acquisition.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Presentation Skills

Formazione

Medical Degree (MD)

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 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 will provide strategic and tactical clinical leadership for evaluating and planning clinical development programs, including protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products across markets. Additionally, the person will review scientific data and perform due diligence for in-licensing potential assets. Acting as a conduit between internal and external stakeholders, the individual will oversee product development and lifecycle management 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 EU/USFDA.

Job Responsibilities:

• Critically evaluate clinical data of investigational products 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 support, and regulatory interactions.
• 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.
• Provide medical/scientific expertise to global medical affairs regarding licensing and acquisition opportunities for late-stage and marketed dermatology products.
• Plan and support publication and presentation of data at international conferences, symposia, and journals.
• Ensure all activities comply 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 in pharmaceutical/biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional teams within a complex matrix organization.
• Experience in financial and resource planning and management.
• Excellent presentation and communication skills to meet both scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across Glenmark's geographies and external partners.