Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Salerno; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Lead to oversee respiratory drug development. The role involves managing clinical projects, engaging with global regulators, and ensuring compliance with industry standards. Candidates should have extensive experience in pulmonary medicine and a strong background in drug development and regulatory interactions.

Competenze

• Minimum 18 years practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects.
• Expertise in drug development and regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and CRO capabilities.
• Engage in discussions with regulators for drug approvals.

Conoscenze

Drug development

Regulatory interactions

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

Role Overview:

This position is intended to head and support the clinical development of new drugs, focusing on innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligned with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

1. Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all deliverables.
2. Contribute to and review key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
3. Review CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMP, and investigator/site lists.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
5. Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
6. Attend and review minutes from internal or joint CRO-sponsor medical monitoring safety meetings.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM prior to DBL, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.
10. Engage in discussions with regulators on clinical development pathways and facilitate faster approvals.
11. Develop projects and evaluate new business opportunities or internal targets for pipeline expansion in respiratory, allergy, and inflammation areas.
12. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

MD / MS in Internal and Pulmonary / Critical Care Medicine.

Experience:

Minimum 18 years practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry or clinical projects in drug development, including regulatory interactions.

Knowledge and Skills:

Expertise in drug development, scientific advocacy, and regulatory interactions.

Behavioral Attributes:

Strong decision-making and influencing skills, with good interpersonal abilities.