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

Glenmark Pharmaceuticals; Ferrara; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Clinical Development Director with a strong dermatology background. This pivotal role involves leading clinical strategies from pre-registration to commercialization of innovative dermatology products. The ideal candidate will leverage extensive experience in clinical development and regulatory interactions, ensuring compliance and fostering partnerships with key stakeholders. Join a forward-thinking organization dedicated to advancing dermatological care and make a significant impact in the field. If you are passionate about driving clinical excellence and innovation, this opportunity is designed for you.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration.
• Understanding of drug development processes for dermatology products.

Mansioni

• Evaluate clinical data to inform development strategies for registration.
• Collaborate with cross-functional teams for protocol development and execution.
• Provide medical monitoring for dermatology clinical studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data evaluation and interpretation

Cross-functional team collaboration

Presentation skills

Formazione

MD or equivalent postgraduate medical degree

Descrizione del lavoro

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

Please Note: Incumbent can be based anywhere in Europe or 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, to achieve Glenmark’s objectives in various markets. The person shall lead strategic and tactical clinical development efforts, including protocol preparation, trial execution, and regulatory interactions for registration trials and lifecycle management of innovative dermatology products across markets. Additionally, they shall review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit between internal and external stakeholders throughout product development and lifecycle.

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:

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration purposes.
2. Collaborate with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, execution, and regulatory interactions.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and health professionals to foster 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 international conferences, symposia, and journals.
7. Ensure compliance with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

1. MD or equivalent postgraduate medical degree in dermatology.
2. Approximately 10-12 years of experience in clinical sciences, regulatory registration dermatology studies, or Phase 1-3 clinical development in pharmaceutical/biopharmaceutical companies.
3. Understanding of drug development processes and regulatory pathways for dermatology products globally.
4. Ability to evaluate, interpret, and present complex clinical trial data.
5. Experience working in cross-functional teams within a complex matrix organization.
6. Proficiency in financial and resource planning and management.
7. Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
8. Ability to coordinate with multiple stakeholders across geographies.