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

Infovista; La Spezia; Remoto; EUR 80.000 - 150.000; 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 product commercialization. The ideal candidate will leverage their extensive experience in clinical sciences and regulatory processes to guide innovative dermatological products through the complex landscape of drug development. You will collaborate with diverse teams, ensuring compliance and scientific excellence while fostering relationships with key stakeholders. If you are a visionary leader passionate about advancing dermatological care, this opportunity is tailor-made for you.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration.
• Strong understanding of drug development processes for dermatology.

Mansioni

• Evaluate clinical data for registration strategies and collaborate with cross-functional teams.
• Provide medical monitoring and maintain partnerships with dermatology stakeholders.

Conoscenze

Clinical Development

Dermatology Expertise

Regulatory Interactions

Data Evaluation

Cross-Functional Collaboration

Communication Skills

Formazione

MD or equivalent postgraduate degree in dermatology

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 high-level clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, aligning with Glenmark’s objectives across various markets. The role involves strategic and tactical clinical leadership to support successful evaluation, planning of clinical development programs, protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration trials and lifecycle management of dermatology products. Additionally, the person will review scientific data, perform due diligence for in-licensing potential assets, and act as a conduit among internal and external stakeholders throughout the product lifecycle. The ideal 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 to inform clinical development strategies for registration purposes.
2. Collaborate 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. 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.
6. Plan and oversee publication and presentation of data at conferences, symposia, and journals.
7. Ensure compliance with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• MD or equivalent postgraduate degree in dermatology with approximately 10-12 years of experience in clinical sciences, regulatory registration, or clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products globally.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional, matrix organizations, with skills in financial/resource planning and management.
• Excellent communication and presentation skills, capable of coordinating with multiple stakeholders across geographies.