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

Glenmark Pharmaceuticals; Chieti; Remoto; EUR 100.000 - 160.000; 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, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. The ideal candidate will leverage their extensive experience in clinical sciences and dermatology to drive innovative product development. With a focus on scientific advocacy and stakeholder engagement, this position offers a unique opportunity to influence the future of dermatological therapies across various markets. Join a forward-thinking company committed to advancing healthcare solutions.

Competenze

• 10-12 years of experience in clinical sciences or clinical development.
• Trained dermatologist with regulatory knowledge.

Mansioni

• Evaluate clinical data to inform development strategies.
• Collaborate with teams for planning and execution support.
• Provide medical monitoring for dermatology studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory interactions

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 US.

The Clinical Sciences/Clinical Development Director for dermatology shall be responsible for providing a high level of clinical expertise in 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 person shall act as the conduit between internal and external stakeholders throughout the development and lifecycle of the products. 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 with various teams (Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, 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 ensure 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 the 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 in 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.
• Experience in financial and resource planning and management.
• Excellent presentation and communication skills, with the ability to meet scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across different geographies.