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

Glenmark Pharmaceuticals; Pisa; Remoto; EUR 80.000 - 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 clinical expertise from pre-registration to commercialization of innovative dermatology products. The successful candidate will lead strategic clinical development programs, ensuring compliance with regulations while collaborating with various stakeholders. With a focus on scientific understanding and advocacy, this position offers the opportunity to influence the future of dermatological treatments. Join a dynamic team committed to excellence and innovation in the pharmaceutical landscape.

Competenze

• 10-12 years experience in clinical sciences and regulatory registration studies.
• Trained dermatologist with experience in Phase 1-3 clinical development.

Mansioni

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

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data evaluation and interpretation

Cross-functional collaboration

Presentation and 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 the 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 the commercialization of innovative products, aiming to achieve Glenmark’s objectives in various markets. The person will provide strategic and tactical clinical leadership to enable successful evaluation and planning of clinical development programs, protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration clinical trials and lifecycle management of innovative, specialty dermatology products across multiple markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The individual will act as a conduit between multiple internal and external stakeholders throughout the development and lifecycle of the 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 including EU/USFDA.

Job Responsibilities:

• Critical evaluation of clinical data of investigational products and similar drugs from a clinical sciences perspective to inform clinical development strategies for registration purposes.
• Collaborate closely with teams such as Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution support, regulatory interactions, etc.
• Medical monitoring and supervision of dermatology clinical studies.
• Develop and maintain collaborative partnerships with dermatology stakeholders, key external experts, and allied health professionals to ensure scientific understanding and advocacy around products and the therapeutic area.
• Provide medical/scientific expertise to the global medical affairs team on due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
• Plan and support publication and presentation of data at international conferences, scientific symposia, and journals, aligning with clinical data generated.
• 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 in dermatology, or Phase 1-3 clinical development within pharmaceutical/biopharmaceutical companies.
• Understanding of the drug development process and regulatory pathways for dermatology products across various 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 experience is essential.
• Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across Glenmark's geographies and external partners.