Director/ Sr Director - Clinical Development (Respiratory)

Buscojobs; Lombardia; In loco; EUR 80.000 - 150.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a Clinical Development Lead to spearhead innovative drug development strategies. This role involves engaging with global regulators, mentoring project teams, and ensuring compliance with regulations while driving clinical studies from concept to approval. With a focus on respiratory programs, the ideal candidate will leverage their extensive experience in the pharmaceutical sector to influence and shape clinical pathways. Join a dynamic team dedicated to advancing healthcare solutions and making a significant impact in the field of medicine.

Competenze

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

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Engage with regulators to facilitate faster drug approvals.
• Review and contribute to key study documents.

Conoscenze

Drug Development Expertise

Regulatory Interaction

Clinical Project Management

Decision-Making Skills

Interpersonal Skills

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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. The role involves aligning development strategies with the company's business objectives, engaging with global regulators on respiratory clinical development pathways to facilitate drug approvals, reviewing and conducting due diligence on in-licensing respiratory molecules, and participating in key meetings such as ad boards and global respiratory forums.

Job Responsibilities

1. Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring the timely delivery of all objectives.
2. Contribute to and review key study documents, including 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 protocol-related queries 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 medical monitoring safety meetings and review medical meeting minutes.
7. Review blinded medical coding for adverse events, concomitant medications, and medical history, participate in BDRM prior to database lock, and interpret efficacy and safety data post-unblinding.
8. Support business development activities for respiratory programs, including new and lifecycle management programs, and collaborate with Medical Affairs and BD teams.
9. Maintain close collaboration with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.
10. Engage with regulators on clinical development pathways to facilitate faster approvals.
11. Develop new projects and evaluate business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, overseeing 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 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.