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

Silverpush; Roma; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading company seeks a Clinical Development Director for dermatology, responsible for strategic clinical leadership from pre-registration to commercialization. The role involves collaboration with various teams and stakeholders, providing expertise in clinical development and regulatory interactions. The ideal candidate is a trained dermatologist with extensive experience in clinical sciences and drug development processes.

Competenze

• Approximately 10-12 years of experience in clinical sciences.
• Experience in regulatory registration studies or Phase 1-3 clinical development.

Mansioni

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

Conoscenze

Clinical Development

Communication

Collaboration

Formazione

Medical degree (MD) 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, including evaluation and planning of clinical development programs, protocol development, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products. Additionally, the person will review scientific data and perform due diligence for in-licensing potential assets. Acting as a conduit, they will liaise with internal and external stakeholders throughout product development and lifecycle management. The ideal candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators such as the EU and 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, and regulatory interactions.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain collaborations with dermatology stakeholders, external experts, and allied health professionals to foster scientific understanding and advocacy.
5. Support global medical affairs by providing expertise on due diligence for licensing and acquisition of new products, including late-stage compounds 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:

• 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 within pharmaceutical/biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
• Ability to evaluate, interpret, and present complex clinical trial data.
• Experience working in cross-functional teams within complex matrix organizations.
• Experience in financial and resource planning and management.
• Excellent communication and presentation skills, capable of meeting scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across Glenmark’s geographies.