Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Lead to spearhead innovative drug development in respiratory medicine. The role involves managing clinical projects, engaging with global regulators, and supporting end-to-end drug development processes. Candidates should possess extensive experience in pulmonary clinical practice and the pharmaceutical industry, with a strong background in regulatory affairs and drug development.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project development.
• Expertise in regulatory interactions.

Mansioni

• Lead and manage clinical sciences respiratory projects.
• Review and contribute to key study documents.
• Engage in discussions with global regulators.

Conoscenze

Drug development

Regulatory engagement

Scientific advocacy

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 aligning with the company's business objectives. The role involves discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, 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, ensuring timely delivery of all deliverables.
2. Review and contribute to key study 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 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 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, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings.
10. Engage in discussions with regulators on clinical development pathways and expedite drug approvals.
11. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline.
12. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

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

Experience :

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

Knowledge and Skills :

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

Behavioral Attributes :

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