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

Glenmark Pharmaceuticals; Plasencia; 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 high-level clinical expertise throughout the product lifecycle, from pre-registration to commercialization. The ideal candidate will lead strategic clinical development programs, collaborate with cross-functional teams, and ensure compliance with regulatory standards. With a strong emphasis on stakeholder engagement and scientific advocacy, this position offers a unique opportunity to influence innovative dermatological products on a global scale. If you are a seasoned dermatologist with a passion for clinical development, this role could be your next big career move.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration studies.
• Ability to evaluate and interpret complex clinical trial data.

Mansioni

• Evaluate clinical data to inform development strategies for registration.
• Collaborate with various teams for planning and execution support.

Conoscenze

Dermatology

Clinical Development

Regulatory Knowledge

Data Evaluation

Cross-Functional Collaboration

Presentation Skills

Formazione

MD or equivalent postgraduate medical degree 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 a high level of clinical expertise in Dermatology from the pre-registration stage to the commercialization of innovative products, aligning with Glenmark’s objectives across various markets. The person shall provide strategic and tactical clinical leadership for evaluating and planning clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of dermatology products globally. Additionally, the role involves reviewing scientific data, performing due diligence for in-licensing potential assets, and acting as a conduit between internal and external stakeholders throughout the product development lifecycle.

The 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 US FDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational and similar drugs to inform clinical development strategies for registration purposes.
2. Collaborate closely with Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and Intellectual Property teams for planning, protocol development, execution 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 in due diligence for licensing and acquisition of new products, including late-stage and marketed assets.
6. Plan and oversee the publication and presentation of data at international conferences, symposia, and in scientific journals.
7. Ensure all activities comply with Glenmark standards, SOPs, and external regulations.

Knowledge and Experience:

• MD or equivalent postgraduate medical degree in dermatology.
• Approximately 10-12 years of experience in clinical sciences, regulatory registration studies, or Phase 1-3 clinical development within pharmaceutical or biopharmaceutical companies.
• Understanding of drug development processes and regulatory pathways in dermatology across various markets.
• Ability to evaluate and interpret complex clinical trial data and present findings effectively.
• Proficiency in working within cross-functional, matrix organizations.
• Experience in financial and resource planning and management.
• Excellent presentation and communication skills to meet scientific and commercial needs.
• Ability to coordinate with multiple stakeholders across geographies.