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

Infovista; Trieste/Trst; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves leading clinical programs from pre-registration to commercialization, ensuring compliance with regulatory standards while driving innovative product strategies. The ideal candidate will leverage their extensive dermatology expertise and clinical development experience to evaluate data, collaborate with cross-functional teams, and engage with external stakeholders. This is an exciting opportunity to influence the future of dermatological products on a global scale, making a significant impact in the healthcare sector.

Competenze

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

Mansioni

• Evaluate clinical data to inform development strategies.
• Collaborate with teams for trial support and regulatory interactions.
• Provide medical monitoring of dermatology clinical studies.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Cross-Functional Collaboration

Formazione

Medical Degree (MD)

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 pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives across various markets. The person will provide strategic and tactical clinical leadership for successful evaluation and planning of clinical development programs, including protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products globally. Additionally, the role involves reviewing scientific data and performing due diligence for in-licensing potential assets. The person acts as a conduit between internal teams and external stakeholders throughout the product development lifecycle. The ideal 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 USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration purposes.
2. Collaborate with various teams (Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Medical Affairs, Intellectual Property) for planning, protocol development, trial support, 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 dermatology products.
6. Plan and oversee publication and presentation of data at conferences, 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 studies, or clinical development within pharma/biotech companies.
• Understanding of drug development processes and regulatory pathways in various markets.
• Ability to evaluate, interpret, and present complex clinical data.
• Experience working in cross-functional, matrix organizations, with skills in resource planning, management, and effective communication.