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

Glenmark Pharmaceuticals; Rimini; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a dynamic Clinical Development Director specializing in dermatology. This role involves providing high-level clinical expertise from pre-registration to commercialization of innovative products. You will lead strategic clinical initiatives, manage regulatory interactions, and collaborate with cross-functional teams to ensure successful product development. The ideal candidate will have a medical degree and extensive experience in clinical sciences, with a strong understanding of dermatology and regulatory processes. Join a forward-thinking company and make a significant impact in the dermatology field.

Competenze

• 10-12 years of experience in clinical sciences and regulatory studies.
• Strong understanding of drug development processes for dermatology.

Mansioni

• Evaluate clinical data to inform development strategies for registration.
• Collaborate with teams for planning, protocol development, and execution.

Conoscenze

Clinical Development

Dermatology Expertise

Regulatory Interactions

Data Evaluation

Cross-Functional Collaboration

Communication Skills

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 high-level clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives in various markets. The person shall provide strategic and tactical clinical leadership for evaluating and planning clinical development programs, preparing protocols, executing trials from a medical perspective, and managing regulatory interactions for registration trials and lifecycle management of specialty dermatology products across markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. Acting as a conduit, they will liaise with internal and external stakeholders throughout product development and lifecycle management.

Job Responsibilities:

1. Critically evaluate clinical data of investigational products and similar drugs to inform clinical development strategies for registration.
2. Collaborate with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, trial 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 in due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan and oversee publication and presentation of data at international 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 registration studies, or Phase 1-3 clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional teams within complex matrix organizations.
• Proficiency in financial and resource planning and management.
• Excellent communication and presentation skills, capable of meeting scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across Glenmark’s geographies.