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

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

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology to lead innovative product evaluations from pre-registration to commercialization. This role involves strategic clinical leadership, collaboration with cross-functional teams, and ensuring compliance with regulatory standards. The ideal candidate will be a trained dermatologist with extensive experience in clinical development and a deep understanding of the drug development process. Join this dynamic team and make a significant impact on the future of dermatological therapies across various markets.

Competenze

• 10-12 years of experience in clinical sciences and regulatory studies in dermatology.
• Ability to evaluate and present complex clinical trial data.

Mansioni

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

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data evaluation and interpretation

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 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 individual shall act as the 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.

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 various teams (including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for planning, protocol development and finalization, execution support, and regulatory interactions.
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 therapeutic areas.
5. Support global medical affairs teams with medical/scientific expertise 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, scientific symposia, and journals in line with generated clinical data.
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 in dermatology, or Phase 1-3 clinical development within pharmaceutical or 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, capable of meeting scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across geographies within and outside Glenmark.