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

Silverpush; Milano; Remoto; EUR 100.000 - 160.000; Tempo pieno

Descrizione del lavoro

An innovative firm is seeking a Clinical Development Director specializing in dermatology to lead high-level clinical strategies from pre-registration to commercialization. This role involves critical evaluation of clinical data, collaboration with diverse teams, and ensuring compliance with regulatory standards. The ideal candidate will possess a medical degree and extensive experience in clinical sciences, making significant contributions to product lifecycle management and strategic partnerships in dermatology. Join a forward-thinking organization that champions scientific understanding and advocacy in the dermatological field.

Competenze

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

Mansioni

• Evaluate clinical data for registration strategies.
• Collaborate with cross-functional teams for protocol development.
• Ensure compliance with standards and regulations.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Communication Skills

Formazione

Medical Degree (MD or equivalent)

Descrizione del lavoro

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

lifeworq.com

Please Note: Incumbent can be based anywhere in Europe or the US.

The Clinical Sciences/Clinical Development Director for dermatology will be responsible for providing high-level clinical expertise in Dermatology, from pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives across various markets. The person will lead strategic and tactical clinical development activities, including protocol development, trial execution, regulatory interactions for registration trials, and lifecycle management of dermatology products. Additionally, the role involves reviewing scientific data and performing due diligence for in-licensing potential assets. Acting as a conduit, the person will coordinate with internal teams 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 and US FDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational 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, and regulatory interactions.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop partnerships with dermatology stakeholders, external experts, and health professionals to promote scientific understanding and advocacy.
5. Support global medical affairs with scientific expertise on licensing and acquisition opportunities for late-stage and marketed products.
6. Plan and oversee 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:

1. Medical degree (MD or equivalent) in dermatology with 10-12 years of experience in clinical sciences, regulatory registration studies, or Phase 1-3 clinical development in pharma/biopharma.
2. Deep understanding of drug development processes and regulatory pathways for dermatology in various markets.
3. Ability to evaluate, interpret, and present complex clinical data.
4. Experience working in cross-functional teams within a matrix organization.
5. Proven skills in financial and resource planning and management.
6. Excellent communication and presentation skills, capable of addressing scientific and commercial audiences.
7. Ability to coordinate with multiple stakeholders across different geographies.