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

JR Italy; Monza; Remoto; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading company is seeking a Clinical Sciences/Clinical Development Director specializing in dermatology. The role involves providing clinical expertise from product development to commercialization, ensuring compliance with regulations, and collaborating with various internal and external stakeholders to support clinical studies and product lifecycle management.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Experience with regulatory registration dermatology studies.

Mansioni

• Evaluate clinical data to inform development strategies.
• Collaborate with teams for protocol development and regulatory interactions.
• Provide oversight for dermatology clinical studies.

Conoscenze

Clinical Development

Dermatology

Communication

Formazione

MD or equivalent postgraduate medical degree

Descrizione del lavoro

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 meet Glenmark’s objectives across various markets. The person will offer strategic and tactical clinical leadership for evaluating and planning clinical development programs, including protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration trials and lifecycle management of dermatology products globally. Additionally, they will review scientific data and conduct due diligence for in-licensing potential assets. The role acts as a conduit between internal teams and external stakeholders throughout the product 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.
2. Collaborate with various teams (Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Medical Affairs, Intellectual Property) for planning, protocol development, execution support, and regulatory interactions.
3. Provide medical monitoring and oversight for 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 dissemination of data through publications, presentations at conferences, symposia, and journals.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• MD or equivalent postgraduate medical degree in dermatology.
• Approximately 10-12 years of experience in clinical sciences, regulatory registration dermatology studies, or clinical development within pharmaceutical/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 teams within complex matrix organizations.
• Experience with financial/resource planning and management.
• Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across different geographies.