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

Glenmark Pharmaceuticals; Frosinone; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

An established industry player seeks a Clinical Development Director specializing in dermatology. This pivotal role involves leading clinical strategies from pre-registration to commercialization of innovative dermatology products. The ideal candidate will leverage their extensive clinical expertise, guiding cross-functional teams and ensuring compliance with regulatory standards. With a focus on collaboration and strategic planning, this position offers the chance to significantly impact product development and lifecycle management. If you are a trained dermatologist with a passion for advancing dermatological care, this opportunity is tailored for you.

Competenze

• 10-12 years experience in clinical sciences and regulatory studies in dermatology.
• Ability to evaluate and present complex clinical trial data.

Mansioni

• Evaluate clinical data for registration purposes.
• Collaborate with cross-functional teams for protocol development.
• Provide medical monitoring for dermatology studies.

Conoscenze

Dermatology Expertise

Clinical Development

Regulatory Knowledge (EU/USFDA)

Data Evaluation and Interpretation

Cross-Functional Team 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 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 to facilitate successful evaluation, planning of clinical development programs, protocol preparation, trial execution from a medical perspective, regulatory interactions for registration trials, and lifecycle management of innovative, specialty dermatology products across markets. Additionally, the individual shall review scientific data and perform due diligence for in-licensing potential assets. The role involves acting 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 the EU and USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational and similar drugs from a clinical sciences perspective to inform 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, execution support, regulatory interactions, etc.
3. Provide medical monitoring and supervision of dermatology clinical studies.
4. Develop and maintain collaborative partnerships with dermatology stakeholders, external experts, and health professionals to ensure scientific understanding and advocacy.
5. Support global medical affairs in due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan the publication and presentation of clinical data at international conferences, symposia, and in scientific journals.
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 in dermatology, or Phase 1-3 clinical development in pharmaceutical/biopharmaceutical industries.
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 complex matrix organizations.
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, both within and outside the organization.