Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Senior Clinical Development Lead focused on respiratory projects. This role will involve managing clinical studies, engaging with regulators, and driving innovative drug development strategies. The ideal candidate should possess an MD or MS in relevant fields and significant experience in pulmonary medicine and the pharmaceutical industry.

Competenze

• 18 years as a practicing pulmonary clinical professional.
• Over 5 years in pharmaceutical industry or clinical development.
• Strong decision-making and influencing skills.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to study-related documents and CRO medical monitoring.
• Engage with regulators on clinical pathways and approvals.
• Drive strategy and delivery of respiratory programs.

Conoscenze

Drug development

Scientific advocacy

Regulatory affairs

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal Medicine, Pulmonary, or Critical Care Medicine

Descrizione del lavoro

Pls note : Incumbent can be based anywhere in Europe or the US.

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. Responsibilities include discussions with global regulators on respiratory clinical development pathways for drug approval facilitation, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities : Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones. Key duties include :

1. Contributing to and reviewing study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
2. Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
3. Guiding on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, investigators, and study teams.
4. Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing issues impacting safety or study integrity.
5. Participating in internal or joint CRO-sponsor medical safety meetings and reviewing medical meeting minutes.
6. Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, and interpreting efficacy and safety data post-unblinding.
7. Supporting business development for respiratory programs, medical affairs, and lifecycle management, including new opportunities.
8. Collaborating with internal stakeholders across departments.
9. Participating in ad boards, respiratory forums, and meetings.
10. Engaging with regulators on clinical pathways and approval processes.
11. Evaluating new projects and business opportunities for pipeline expansion in respiratory, allergy, and inflammation.
12. Driving the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education : Educational Qualifications : MD / MS in Internal Medicine, Pulmonary, or Critical Care Medicine.

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

Knowledge and Skills : Expertise in drug development, scientific advocacy, and regulatory affairs.

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