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

Infovista; Cagliari; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Sciences/Clinical Development Director specializing in dermatology. This pivotal role involves providing strategic clinical leadership from pre-registration to commercialization of innovative dermatology products. The ideal candidate will possess a medical degree and extensive experience in clinical development, regulatory interactions, and data evaluation. Join a dynamic team focused on advancing dermatology solutions while collaborating with various stakeholders to drive scientific understanding and advocacy. This position offers the opportunity to make a significant impact in a rapidly evolving field.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Trained dermatologist with regulatory registration experience.

Mansioni

• Evaluate clinical data for registration strategies.
• Collaborate with cross-functional teams for clinical development.
• Oversee medical monitoring of dermatology studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU and US FDA)

Data evaluation and presentation

Cross-functional collaboration

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 provide 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 offer strategic and tactical clinical leadership for evaluating and planning clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products. Additionally, they will review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit between internal and external stakeholders throughout the product lifecycle. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators such as the EU and US FDA.

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, regulatory interactions, etc.
3. Oversee medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain partnerships with dermatology stakeholders, external experts, and healthcare professionals to foster scientific understanding and advocacy.
5. Support global medical affairs in due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan dissemination of data through publications, conference presentations, symposia, and journals.
7. 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 clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products across markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional, matrix organizations, with skills in resource and financial planning.
• Excellent communication and presentation skills, capable of addressing both scientific and commercial audiences.
• Ability to coordinate with multiple stakeholders across various geographies.