Clinical Development Director

Glenmark Pharmaceuticals; Pavia; Ibrido; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Sciences / Clinical Development Director specializing in dermatology. The role involves providing strategic and tactical clinical leadership for innovative dermatology products from pre-registration to commercialization while ensuring compliance with regulatory standards.

Competenze

• Minimum 10-12 years of experience in clinical sciences or clinical development for dermatology.
• Experience working with regulators including EU and USFDA.
• Ability to interpret and present complex clinical trial data.

Mansioni

• Lead the clinical development strategy for dermatology products.
• Collaborate with cross-functional teams for clinical planning and protocol development.
• Medical monitoring of clinical studies and ensuring regulatory compliance.

Conoscenze

Strategic planning

Clinical data evaluation

Regulatory knowledge

Cross-functional collaboration

Presentation skills

Formazione

MD or equivalent post graduate medical degree in dermatology

Descrizione del lavoro

Incumbent can be based anywhere in Europe or US

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

Job Responsibility :

• Critical evaluation of clinical data of the investigational products, similar drugs from clinical sciences perspective to build a foundation for clinical development strategies for registrational purposes.
• Closely collaborates with various teams (including Clinical Development team members, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) for clinical development planning, protocol development & finalization, execution support, regulatory presentations and approvals interactions, etc.
• Medical monitoring and supervision of the clinical dermatology studies
• Develops and maintains collaborative partnerships with dermatology stakeholders , key external experts, and allied health professionals ensuring scientific understanding and advocacy around products and therapeutic area
• Global medical affairs team to provide medical / scientific expertise on due diligence of new product licensing and acquisition opportunities for late-stage compounds and marketed products.
• Plans publication / presentation of data in international conferences, scientific symposia’s, etc and / or journals in line with the clinical data generated
• Ensures that all activities are carried out in compliance with Glenmark standards, standard operating procedures and external regulations

Knowledge and Experience :

• Medical educational background (MD or equivalent post graduate medical degree) in dermatology with an approximate experience of 10 to 12 years of working in clinical sciences, regulatory registration dermatology studies or Phase 1- Phase 3 clinical development function of pharmaceutical / biopharmaceutical companies. Understanding of the overall drug development process and regulatory path for dermatology products in various markets. Able to evaluate, interpret and present highly complex data from clinical trials. Ability to work in cross functional groups and teams with a complex matrix organization. Experience of financial and resource planning and management is essential. Excellent presentation and communication skills with an ability to meet the scientific, commercial needs. Ability to co-ordinate with multiple stakeholders across Glenmark geographies of various markets both within and outside the organization.