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

Glenmark Pharmaceuticals; Novara; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in Dermatology. This pivotal role involves providing strategic clinical leadership for innovative dermatology products from pre-registration to commercialization. The ideal candidate will have a strong background in clinical sciences, regulatory interactions, and experience in managing cross-functional teams. You will be at the forefront of evaluating clinical data, collaborating with stakeholders, and ensuring compliance with industry standards. Join a dynamic team and make a significant impact in the dermatology field.

Competenze

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

Mansioni

• Evaluate clinical data for investigational products to inform development strategies.
• Collaborate with various teams for planning and execution of clinical studies.
• Develop partnerships with dermatology stakeholders and experts.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Cross-Functional Collaboration

Communication 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 Dermatology, from pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives across various markets. The person will provide strategic and tactical clinical leadership to enable successful evaluation, planning of clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration 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 will 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. 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 various teams (including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for planning, protocol development and finalization, execution support, regulatory interactions, etc.
3. Medical monitoring and supervision of clinical dermatology 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 expertise on due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan publication and presentation of data at international conferences, scientific symposia, and journals in line with the clinical data generated.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

1. 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.
2. Understanding of the drug development process and regulatory pathways for dermatology products in various markets.
3. Ability to evaluate, interpret, and present complex clinical trial data.
4. Experience working in cross-functional teams within a complex matrix organization.
5. Experience in financial and resource planning and management.
6. Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
7. Ability to coordinate with multiple stakeholders across Glenmark’s geographies in various markets.