Clinical Development Director

Buscojobs; Friuli-Venezia Giulia; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading company in drug development seeks a Clinical Development Lead based in Europe or the US. The role includes managing respiratory clinical projects, ensuring compliance with regulations, engaging with global regulators, and driving strategies for drug approvals and portfolio management.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical project management.
• Experience with regulatory interactions for drug development.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review and contribute to key study documents.
• Engage with regulators on clinical development pathways.

Conoscenze

Decision-making

Interpersonal skills

Expertise in drug development

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, aligning 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 presentations in ad boards and global respiratory meetings.

Job Responsibilities :

1. Lead, manage, and mentor Clinical Sciences respiratory projects ensuring 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 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 issues 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, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings.
10. Engage with regulators on clinical development pathways and accelerate drug approvals.
11. Develop projects and evaluate new business opportunities or internal drug candidates for pipeline expansion in respiratory, allergy, and inflammation areas.
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 for drug development.

Knowledge and Skills : Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes : Strong decision-making and influencing skills, good interpersonal skills.