Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Reggio Emilia; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a head of clinical development for respiratory programs. This role involves overseeing clinical studies, engaging with global regulators, and ensuring compliance with regulations. The ideal candidate will have extensive experience in pulmonary medicine and drug development, demonstrating strong leadership and decision-making skills.

Competenze

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

Mansioni

• Lead and manage clinical sciences respiratory projects.
• Contribute to key study documents and review CRO medical monitoring.
• Engage with regulators on clinical development pathways.

Conoscenze

Drug Development

Scientific Advocacy

Decision-Making

Interpersonal Skills

Formazione

MD / MS MD 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 and 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 timely delivery of all milestones.
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 safety meetings and review medical meeting minutes.
7. Review blinded medical coding for AEs, SAEs, medications, and medical history, and participate in BDRM prior to database lock, providing primary interpretation post-unblinding.
8. Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including 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 for faster approvals.
12. Evaluate new business opportunities and internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline.
13. Drive the overall strategy and delivery of respiratory programs 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 more than 5 years in the pharmaceutical industry or clinical projects in clinical development, including regulatory interactions.

Knowledge and Skills (Functional / Technical) :

Expertise in drug development and scientific advocacy with policymakers/regulators.

Behavioral Attributes :

The candidate should demonstrate good decision-making and influencing skills, along with strong interpersonal abilities.