Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Head of Clinical Development to oversee the clinical development of new respiratory drugs. This role involves strategic leadership, regulatory engagement, and collaboration across departments to ensure timely delivery of projects. Candidates must have extensive experience in pulmonary medicine and drug development, with a strong background in clinical project management.

Competenze

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

Mansioni

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

Conoscenze

Drug development

Scientific advocacy

Regulatory engagement

Decision-making

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, 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. 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 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.
4. Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, 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 data impacting subject safety or study integrity.
6. Attend internal or joint CRO-sponsor medical monitoring 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 after unblinding.
8. Support business development for respiratory programs and portfolio, 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 meetings; engage with regulators on development pathways and approval strategies.
11. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline expansion and growth.
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 pharmaceutical industry/clinical project management, including regulatory interactions.

Knowledge and Skills :

Drug development, scientific advocacy, and regulatory engagement.

Behavioral Attributes :

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