Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Casalnuovo di Napoli; Remoto; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Leader to head innovative drug development in respiratory medicine. This role involves managing clinical projects, engaging with global regulators, and ensuring compliance with industry standards. Candidates should possess extensive experience in pulmonary medicine and a strong background in drug development.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and provide guidance on medical questions.
• Collaborate with internal stakeholders and engage with regulators.

Conoscenze

Drug development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

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

Descrizione del lavoro

Note:

The 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, including conception of 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. Responsibilities include 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. 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 process, 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 data 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, participating in BDRM prior to DBL and interpreting efficacy and safety post-unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate closely with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.
11. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline expansion.
12. Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications: MD / MS, with specialization in Internal Medicine, Pulmonary, or 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 development projects, including regulatory interactions.

Knowledge and Skills:

Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes:

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