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

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

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves leading clinical strategies from pre-registration to commercialization of innovative dermatology products. The ideal candidate will leverage their extensive experience in clinical sciences and regulatory processes to drive successful product development and lifecycle management. You will collaborate with diverse teams, ensuring compliance with industry standards while fostering partnerships with external stakeholders. This position offers an exciting opportunity to make a significant impact in the dermatology field, contributing to the advancement of cutting-edge therapies.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Ability to interpret complex clinical trial data.

Mansioni

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

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge (EU/USFDA)

Data Evaluation

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 US.

The Clinical Sciences/Clinical Development Director for dermatology will be responsible for providing high-level clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives across various markets. The role involves strategic and tactical clinical leadership for evaluating and planning clinical development programs, protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products. Additionally, the person will review scientific data and perform due diligence for in-licensing potential assets. They will act as a conduit between internal teams and external stakeholders throughout product development and lifecycle management. 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 support, 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 scientific expertise on licensing and acquisition opportunities for late-stage and marketed dermatology products.
6. Plan dissemination of data through publications, conferences, symposia, and journals.
7. Ensure compliance with Glenmark standards, SOPs, and external regulations in all activities.

Knowledge and Experience:

1. Medical degree (MD or equivalent) in dermatology with 10-12 years of experience in clinical sciences, regulatory registration studies, or clinical development in pharma/biotech sectors.
2. Understanding of drug development processes and regulatory pathways for dermatology products globally.
3. Ability to interpret complex clinical trial data and work effectively in cross-functional, matrix organizations.
4. Experience in financial/resource planning and management.
5. Excellent communication and presentation skills to meet scientific and commercial needs.
6. Ability to coordinate with multiple stakeholders across geographies.