Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Head to lead respiratory projects and engage with global regulators. The ideal candidate will have extensive experience in drug development and a strong educational background in pulmonary medicine. This role involves strategic oversight of clinical studies and collaboration with various stakeholders to ensure successful drug approvals.

Competenze

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

Mansioni

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

Conoscenze

Expertise in drug development

Scientific advocacy with policymakers

Strong decision-making skills

Good interpersonal skills

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 & due diligence of in-licensing respiratory molecules, and presentations at 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 start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.
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 or escalating any data impacting subject 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, participate in BDRM, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.
9. Build and maintain collaboration with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and presentations at respiratory meetings.
11. Engage with regulators on clinical development pathways and faster approvals.
12. Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline, driving program strategy from candidate evaluation to registration.

Knowledge and Education :

Educational Qualifications : MD / MS, MD 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 projects in drug development, 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.