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

Glenmark Pharmaceuticals; Pescara; Remoto; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Director of Clinical Development in Dermatology to lead innovative product evaluations from pre-registration to commercialization. This pivotal role requires a trained dermatologist with extensive experience in clinical sciences and regulatory pathways. You will provide strategic leadership across various markets, ensuring compliance with standards while fostering partnerships with key stakeholders. If you are passionate about advancing dermatological therapies and thrive in collaborative environments, this opportunity is perfect for you.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration.
• Trained dermatologist with experience in Phase 1-3 clinical development.

Mansioni

• Evaluate clinical data for registration purposes and inform development strategies.
• Collaborate with cross-functional teams for trial execution and regulatory interactions.
• Provide medical monitoring and supervision of dermatology clinical studies.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Cross-Functional Collaboration

Presentation 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 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 shall provide strategic and tactical clinical leadership to enable successful evaluation and planning of clinical development programs, including protocol preparation, trial execution from a medical perspective, regulatory interactions for registration clinical trials, and lifecycle management of innovative, specialty dermatology products across 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 product development and lifecycle management in various markets. 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 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, trial execution support, regulatory interactions, etc.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain collaborative partnerships with dermatology stakeholders, key external experts, and allied health professionals to ensure scientific understanding and advocacy for products and the therapeutic area.
5. Work with the global medical affairs team to provide medical/scientific expertise on due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan and support publication and presentation of data at international conferences, scientific symposia, and journals in line with clinical data generated.
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 in pharmaceutical/biopharmaceutical companies.
• Understanding of the drug development process 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 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 and markets.