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

Glenmark Pharmaceuticals; Pistoia; Remoto; EUR 100.000 - 160.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves providing strategic leadership from pre-registration to commercialization of innovative dermatology products. The successful candidate will leverage their extensive clinical expertise and regulatory knowledge to drive clinical development programs, ensuring alignment with business objectives. You'll collaborate with cross-functional teams and external stakeholders, critically evaluate clinical data, and contribute to the scientific community through publications. If you are passionate about advancing dermatological innovations, this opportunity is 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 for registration strategies of dermatology products.
• Collaborate with teams for protocol development and regulatory interactions.

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data evaluation and interpretation

Cross-functional collaboration

Presentation and communication

Formazione

Medical degree (MD)

Experience in clinical sciences

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 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, 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 role acts 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 regulatory agencies including EU/USFDA.

Job Responsibilities:

1. Critically evaluate clinical data of investigational products and similar drugs to build a foundation for clinical development strategies for registration purposes.
2. Collaborate closely with various teams (Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, Intellectual Property) 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 ensure scientific understanding and advocacy around products and therapeutic areas.
5. Support global medical affairs teams with scientific expertise on due diligence for licensing and acquisition of new products, including late-stage compounds and marketed products.
6. Plan and oversee publication and presentation of data at international conferences, symposia, and 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, or Phase 1-3 clinical development within 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 in cross-functional teams within a complex 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. Proven ability to coordinate with multiple stakeholders across geographies and organizations.