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

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

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology to provide strategic leadership in clinical trials from pre-registration to commercialization. This pivotal role involves evaluating clinical data, collaborating with diverse teams, and ensuring compliance with regulatory standards. The ideal candidate will have a medical degree in dermatology and extensive experience in clinical sciences, making impactful contributions to product development and lifecycle management. Join a forward-thinking company dedicated to innovation in dermatology and help shape the future of healthcare.

Competenze

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

Mansioni

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

Conoscenze

Dermatology expertise

Clinical development

Regulatory interactions

Data evaluation

Communication 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 pre-registration to commercialization of innovative products, to achieve Glenmark’s objectives across various markets. The person shall provide strategic and tactical clinical leadership for evaluating and planning clinical development programs, preparing protocols, executing trials from a medical perspective, and managing regulatory interactions for registration trials and lifecycle management of dermatology products. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The role acts as a conduit between internal teams and external stakeholders throughout product development and lifecycle management. The 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, 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 promote scientific understanding and advocacy.
5. Support global medical affairs by providing expertise on licensing and acquisition due diligence for late-stage 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:

1. Medical degree (MD or equivalent) in dermatology with approximately 10-12 years of experience in clinical sciences, regulatory registration studies, or clinical development within pharmaceutical or biopharmaceutical industries.
2. Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
3. Ability to interpret complex clinical trial data and work effectively in cross-functional, matrix organizations.
4. Experience in financial and resource planning and management.
5. Excellent communication and presentation skills, capable of meeting scientific and commercial needs.
6. Ability to coordinate with stakeholders across different geographies and organizations.