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

Glenmark Pharmaceuticals; Trentino-Alto Adige; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Clinical Development Director specializing in dermatology to lead innovative product strategies from pre-registration to commercialization. This pivotal role demands a seasoned dermatologist with extensive experience in clinical sciences and regulatory processes. The ideal candidate will provide strategic leadership, ensuring successful clinical trials and regulatory compliance while fostering collaborations with stakeholders across various markets. Join a dynamic team dedicated to advancing dermatological solutions and making a significant impact in the healthcare landscape.

Competenze

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

Mansioni

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

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge (EU/USFDA)

Data Evaluation and Interpretation

Cross-Functional Team Collaboration

Presentation 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 shall be responsible for providing a high level of clinical expertise in the area of Dermatology, from the pre-registration stage to the commercialization of innovative products, to achieve Glenmark’s objectives in various markets. The person shall provide strategic and tactical clinical leadership to enable successful evaluation and planning of clinical development programs, protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration clinical trials and lifecycle management of innovative, specialty dermatology products across various markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The role acts as a conduit between multiple internal and external stakeholders throughout the development and lifecycle of the products in various markets. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators including EU/USFDA, etc.

Job Responsibilities:

1. Critical evaluation of clinical data of investigational products and similar drugs from a clinical sciences perspective to inform clinical development strategies for registration purposes.
2. Collaborate closely 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. Medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain collaborative partnerships with dermatology stakeholders, external experts, and allied health professionals to ensure scientific understanding and advocacy for the products and therapeutic area.
5. Provide medical/scientific expertise to the global medical affairs team on 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 scientific 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 dermatology studies, or Phase 1-3 clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of the drug development process and regulatory pathways for dermatology products across various markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional teams within a complex matrix organization.
• Experience in financial and resource planning and management.
• Excellent presentation and communication skills to meet scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across Glenmark’s geographies in various markets.