Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Maserà di Padova; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Head to oversee drug development in respiratory medicine. The role involves leading clinical projects, engaging with regulators, and mentoring teams, requiring extensive experience and a strong scientific background. This position offers the opportunity to shape innovative clinical strategies and drive successful drug approvals.

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 documents and CRO medical monitoring capabilities.
• Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

Conoscenze

Scientific advocacy

Drug development expertise

Formazione

MD / MS in Internal and Pulmonary / 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. 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 ensuring timely delivery of all deliverables.
2. Contribute to and review key study 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 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 SAE or SUSAR documents, escalating issues impacting safety or study integrity.
6. Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs and portfolios, including lifecycle management and new program evaluations.
9. Collaborate with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on development pathways.
11. Drive strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education :

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

Experience :

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

Knowledge and Skills :

Strong scientific advocacy, drug development expertise.

Behavioral Attributes :

Decision-making, influencing skills, and good interpersonal skills are essential.