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

Global Business Milano; Milano; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical industry seeks a Clinical Development Director for Dermatology. This role involves providing strategic clinical leadership from pre-registration to commercialization, collaborating with cross-functional teams, and ensuring compliance with all regulations. The ideal candidate will hold a medical degree in dermatology and have substantial experience in clinical development.

Competenze

• 10-12 years of experience in clinical sciences or clinical development in pharma/biotech companies.
• Understanding of drug development processes and regulatory pathways for dermatology products.
• Ability to coordinate with stakeholders across geographies.

Mansioni

• Critically evaluate clinical data of investigational products.
• Collaborate with various teams for planning and protocol development.
• Provide medical monitoring of dermatology clinical studies.

Conoscenze

Clinical expertise in Dermatology

Ability to interpret complex clinical trial data

Excellent communication and presentation skills

Financial/resource planning and management

Formazione

Medical degree (MD or equivalent) in dermatology

Descrizione del lavoro

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

Location: Varese - 19 ore fa

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 across various markets. The person will provide strategic and tactical clinical leadership to support successful evaluation, planning of clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of specialty dermatology products globally. Additionally, the role involves reviewing scientific data and performing due diligence for in-licensing potential assets. The person will act as a conduit between internal teams and external stakeholders throughout product development and lifecycle management. 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 products and similar drugs to inform clinical development strategies for registration purposes.
2. Collaborate with various teams (Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, 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 promote scientific understanding and advocacy.
5. Support global medical affairs with expertise on licensing and acquisition opportunities for late-stage and marketed products.
6. Plan and oversee publication and presentation of data at conferences, symposia, and in journals.
7. Ensure all activities comply 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 studies, or clinical development in pharma/biotech companies.
2. Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
3. Ability to interpret complex clinical trial data and work effectively in cross-functional and matrix organizations.
4. Experience in financial/resource planning and management.
5. Excellent communication and presentation skills, capable of meeting scientific and commercial needs.
6. Ability to coordinate with stakeholders across geographies and organizations.