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

Glenmark Pharmaceuticals; Bologna; 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 leading clinical development programs from pre-registration to commercialization, ensuring compliance with regulatory standards while fostering partnerships with key stakeholders. The ideal candidate will possess a medical degree in dermatology and extensive experience in clinical sciences and regulatory processes. Join a forward-thinking organization that values innovation and excellence in developing dermatological products for global markets.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration studies.
• Ability to interpret complex clinical trial data effectively.

Mansioni

• Evaluate clinical data for registration strategies.
• Collaborate with cross-functional teams for clinical development.
• Provide medical monitoring for dermatology studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data interpretation

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 the 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, to support Glenmark’s objectives across various markets. The person will offer strategic and tactical clinical leadership for evaluating and planning clinical development programs, including protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of innovative dermatology products. Additionally, the role involves reviewing scientific data, performing due diligence for in-licensing potential assets, and acting as a conduit between 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 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 healthcare professionals to foster scientific understanding and advocacy.
5. Support global medical affairs with expertise on due diligence for licensing and acquisition of new products, including late-stage and marketed assets.
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:

• 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/biopharmaceutical sectors.
• Comprehensive understanding of drug development processes and regulatory pathways for dermatology products across markets.
• Ability to interpret and present complex clinical trial data effectively.
• Experience working within cross-functional teams in a matrix organization.
• Proven skills in financial and resource planning and management.
• Excellent communication and presentation skills, with the ability to address scientific and commercial audiences.
• Ability to coordinate with multiple stakeholders across different geographies.