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

Infovista; Belluno; 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 lead innovative product evaluations from pre-registration to commercialization. This role requires a trained dermatologist with extensive experience in clinical sciences and regulatory interactions. You will provide strategic leadership, collaborate with cross-functional teams, and ensure compliance with industry standards. This position offers a unique opportunity to influence the development of specialty dermatology products across various markets, making a significant impact in the field. Join a forward-thinking company dedicated to advancing dermatological care and improving patient outcomes.

Competenze

• 10-12 years experience in clinical sciences and regulatory registration for dermatology.
• Strong understanding of drug development processes and regulatory pathways.

Mansioni

• Evaluate clinical data for registration strategies and collaborate with various teams.
• Provide medical monitoring for dermatology clinical studies and support global medical affairs.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge

Data Evaluation

Cross-Functional Collaboration

Presentation 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 US.

The Clinical Sciences/Clinical Development Director for dermatology shall be responsible for providing a high level of clinical expertise in the area of Dermatology from the pre-registration stage to the commercialization of innovative products, aiming to achieve Glenmark’s objectives in various markets. The person shall provide strategic and tactical clinical leadership to enable successful evaluation and planning of clinical development programs, protocol preparation, trial execution from a medical perspective, and regulatory interactions for registration clinical trials and lifecycle management of innovative, specialty dermatology products across various markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The individual shall act as a conduit between multiple internal and external stakeholders throughout the development and lifecycle of the products in various markets. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators including EU/USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational products and similar drugs from a clinical sciences perspective to inform clinical development strategies for registration purposes.
2. Collaborate closely with various teams (including Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for planning, protocol development, execution support, regulatory interactions, etc.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain collaborative partnerships with dermatology stakeholders, key external experts, and allied health professionals to ensure scientific understanding and advocacy.
5. Support global medical affairs by providing scientific expertise on due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan the publication and presentation of data at international conferences, scientific symposia, and journals in line with generated clinical data.
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 dermatology studies, or Phase 1-3 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. Experience in financial and resource planning and management.
6. Excellent presentation and communication skills, capable of meeting scientific and commercial needs.
7. Ability to coordinate with multiple stakeholders across Glenmark's geographies and external organizations.