Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking a Head of Clinical Development to oversee innovative drug development in the respiratory field. The role requires extensive experience in pulmonary medicine and regulatory interactions, focusing on managing clinical projects and engaging with global regulators to facilitate drug approvals.

Competenze

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

Mansioni

• Lead, manage, and mentor 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

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, 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 participation in ad boards and global respiratory meetings.

Job Responsibilities :

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring the timely delivery of all key 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, MMPs, 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 subject safety or study integrity.
6. Participate in medical monitoring safety meetings and review meeting 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, and medical affairs, including new and lifecycle management programs.
9. Collaborate 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 for faster approvals.
11. Develop projects and evaluate new business opportunities or 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 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 involving clinical development and 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.