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

Infovista; Siena; Remoto; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Sciences Director specializing in dermatology to lead innovative product development from pre-registration to commercialization. This pivotal role requires strategic clinical leadership, overseeing clinical trials, and engaging with regulatory bodies. The ideal candidate will possess a medical degree in dermatology and significant experience in clinical development, ensuring compliance with standards while fostering partnerships with stakeholders. Join a dynamic team where your expertise will drive impactful advancements in dermatological care and product success across various markets.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration studies.
• Trained dermatologist with expertise in drug development processes.

Mansioni

• Evaluate clinical data to inform development strategies for registration.
• Collaborate with teams for planning and regulatory interactions.
• Provide medical monitoring for dermatology clinical studies.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge

Data evaluation and interpretation

Cross-functional collaboration

Presentation 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 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. This role involves strategic and tactical clinical leadership to evaluate and plan clinical development programs, including protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of specialty dermatology products. Additionally, the person will review scientific data and perform due diligence for in-licensing potential assets. Acting as a conduit between internal teams and external stakeholders, the individual 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 closely with teams including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property for planning, protocol development, trial 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 foster scientific understanding and advocacy.
5. Support global medical affairs with expertise on licensing and acquisition opportunities for late-stage and marketed products.
6. Plan and oversee publication and presentation of data at conferences, symposia, and in journals, aligned with clinical findings.
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 in pharmaceutical/biopharmaceutical companies.
2. Understanding of drug development processes and regulatory pathways for dermatology products in various markets.
3. Ability to evaluate, interpret, and present complex clinical trial data.
4. Experience working in cross-functional teams within a complex matrix organization.
5. Financial and resource planning experience is essential.
6. Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
7. Ability to coordinate with multiple stakeholders across geographies.