Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Napoli; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Lead to oversee the clinical development of respiratory drugs. This role involves managing projects, engaging with regulators, and collaborating across departments to ensure successful drug approvals. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in the pharmaceutical industry.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project management.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to and review key study documents.
• Engage in discussions with regulators on clinical development pathways.

Conoscenze

Drug development

Scientific advocacy

Regulatory processes

Decision-making

Interpersonal abilities

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 aligned with the company's business objectives. The role involves 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 milestones.
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 start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
4. Guide 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 any data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor 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, including new and lifecycle management programs.
9. Collaborate closely with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.
10. Engage in discussions with regulators on clinical development pathways and accelerate 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 in 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 management, including regulatory interactions.

Knowledge and Skills :

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

Behavioral Attributes :

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