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

Glenmark Pharmaceuticals; Milano; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Director for Dermatology. This role involves providing strategic leadership in clinical programs from pre-registration to commercialization, ensuring compliance with regulations, and collaborating with various stakeholders. The ideal candidate will have a medical degree in dermatology and extensive experience in clinical development.

Competenze

• 10-12 years of experience in clinical sciences, regulatory studies, or clinical development.
• Understanding of drug development processes and regulatory pathways.
• Experience in financial/resource planning and management.

Mansioni

• Critical evaluation of clinical data for registration purposes.
• Collaborate with cross-functional teams for planning and execution.
• Medical monitoring and supervision of dermatology clinical studies.

Conoscenze

Clinical expertise in Dermatology

Evaluation of clinical data

Excellent communication skills

Cross-functional teamwork

Formazione

Medical degree (MD) in Dermatology

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 the area of Dermatology from the pre-registration stage to the commercialization of innovative products to achieve Glenmark’s objectives in various markets. The person shall be responsible for providing strategic & 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 various markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The person shall 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:

1. Critical evaluation of clinical data of investigational products and similar drugs to inform clinical development strategies for registration purposes.
2. 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.
3. Medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to ensure scientific understanding and advocacy.
5. Provide medical/scientific expertise for due diligence on licensing and acquisition of new products.
6. Plan and support publication and presentation of data 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 approximately 10-12 years of experience in clinical sciences, regulatory studies, or clinical development in pharma/biopharma companies.
2. Understanding of drug development processes and regulatory pathways in various markets.
3. Ability to evaluate and interpret complex clinical data and work within cross-functional teams.
4. Experience in financial/resource planning and management.
5. Excellent communication and presentation skills, with the ability to coordinate across multiple stakeholders globally.