Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Head to lead and support the clinical development of new drugs, focusing on innovative approaches and regulatory discussions. The ideal candidate will have extensive experience in drug development, strong decision-making skills, and a background in pulmonary medicine.

Competenze

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project management.
• Experience with regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and CRO capabilities.
• Support business development for respiratory programs.

Conoscenze

Drug development

Regulatory interactions

Scientific advocacy

Decision-making

Interpersonal abilities

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 and 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. 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 start-up and RFP processes, including CRO MM 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 related documents, addressing or escalating data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
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, including portfolio management, medical affairs, and lifecycle management programs.
9. Collaborate closely with internal stakeholders across departments such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, and Legal.
10. Participate in ad boards, respiratory forums, and meetings, and engage in discussions with regulators on clinical development pathways.
11. Develop new projects and evaluate business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline.
12. Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications: MD / MS, with specialization in Internal and Pulmonary / Critical Care Medicine.

Experience:

Minimum 18 years of experience as a practicing pulmonary clinical professional, including over 5 years in the pharmaceutical industry or clinical project management, with regulatory interaction experience.

Knowledge and Skills:

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

Behavioral Attributes:

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