Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Sassari; Remoto; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Head to lead innovative drug development in respiratory medicine. The role involves managing clinical projects, engaging with regulators, and ensuring compliance with regulations. Ideal candidates will have 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 pharmaceutical or clinical project development.
• Experience with regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review and contribute to key study documents.
• Participate in medical monitoring safety meetings.

Conoscenze

Expertise in drug development

Scientific advocacy

Regulatory engagement

Strong decision-making

Interpersonal abilities

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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 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. 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 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, escalating data impacting safety or integrity.
6. Participate in medical monitoring safety meetings and review 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, portfolio, medical affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways.
11. Evaluate new business opportunities and internal 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, with specialization in Internal and Pulmonary / Critical Care Medicine.

Experience:

Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in pharmaceutical 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.