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

Glenmark Pharmaceuticals; Livorno; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Director specializing in dermatology. This pivotal role involves leading innovative clinical programs from pre-registration to commercialization, ensuring compliance with regulatory standards. The ideal candidate will have a strong background in dermatology and extensive experience in clinical development, providing strategic leadership and fostering partnerships with stakeholders. Join a forward-thinking organization where your expertise will drive the success of groundbreaking dermatology products across various markets.

Competenze

• 10-12 years of experience in clinical sciences and regulatory registration.
• Ability to present complex clinical trial data effectively.

Mansioni

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

Conoscenze

Dermatology expertise

Clinical development

Regulatory knowledge (EU/USFDA)

Data evaluation and interpretation

Cross-functional collaboration

Communication skills

Formazione

Medical degree (MD or equivalent)

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 in various markets. The person shall provide strategic and tactical clinical leadership for 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 markets. Additionally, the person shall review scientific data and perform due diligence for in-licensing potential assets. The role acts as a conduit between internal and external stakeholders throughout the development and lifecycle of products in various markets. The candidate should be a trained dermatologist with experience in clinical sciences/clinical development for registration assets and familiarity with regulators including 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 such as Clinical Development, Project Management, Clinical Operations, Pharmacovigilance, Regulatory, Global Medical Affairs, and 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 foster scientific understanding and advocacy.
5. Support global medical affairs in due diligence for licensing and acquisition opportunities of late-stage and marketed 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) in dermatology, with 10-12 years of experience in clinical sciences, regulatory registration dermatology studies, or clinical development (Phases 1-3) within pharmaceutical or biopharmaceutical sectors.
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 effectively.
4. Experience working in cross-functional teams within complex matrix organizations.
5. Experience in financial and resource planning and management.
6. Excellent communication and presentation skills, capable of addressing scientific and commercial audiences.
7. Proven ability to coordinate with multiple stakeholders across geographies.