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

Glenmark Pharmaceuticals; Ascoli Piceno; Remoto; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves providing clinical expertise from pre-registration to commercialization of innovative dermatological products. The successful candidate will lead strategic clinical development programs, ensuring compliance with regulatory standards while collaborating with diverse teams. With a focus on data evaluation and stakeholder engagement, this position offers the opportunity to impact product development across various markets. If you have a passion for dermatology and a proven track record in clinical development, this is the perfect opportunity for you.

Competenze

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

Mansioni

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

Conoscenze

Clinical Development

Dermatology Expertise

Regulatory Knowledge

Data Evaluation

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 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, including protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of specialty 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 in various markets. 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 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 partnerships with dermatology stakeholders, external experts, and health professionals to ensure scientific understanding and advocacy.
5. Support global medical affairs with expertise on due diligence for licensing and acquisition of new 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:

1. Medical degree (MD or equivalent) with approximately 10-12 years of experience in clinical sciences, regulatory studies, or Phase 1-3 clinical development in pharmaceutical or 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 within cross-functional teams in a matrix organization.
5. Experience in financial and resource planning and management.
6. Excellent presentation and communication skills, with the ability to meet scientific and commercial needs.
7. Ability to coordinate with multiple stakeholders across geographies.