Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Pisa; In loco; EUR 90.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a senior director for clinical development, focusing on respiratory therapies. This role encompasses oversight of clinical studies, managing respiratory projects, and engaging with global regulators. Ideal candidates will possess extensive experience in pulmonary medicine and the pharmaceutical sector, complemented by strong leadership skills.

Competenze

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

Mansioni

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

Conoscenze

Drug development

Scientific advocacy

Regulatory affairs

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. Responsibilities include 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 : Lead, manage and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables. Key tasks include:

1. Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
2. Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.
3. Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
4. Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing or escalating data impacting safety or integrity.
5. Participating in medical monitoring safety meetings and reviewing medical meeting minutes.
6. Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, and interpreting efficacy and safety data post-unblinding.
7. Supporting business development for respiratory programs, portfolio, medical affairs, and lifecycle management.
8. Collaborating with internal stakeholders across departments.
9. Participating in ad boards, respiratory forums, and meetings.
10. Engaging with regulators on development pathways and approval processes.
11. Developing projects and evaluating new business opportunities or internal drug candidates for respiratory, allergy, and inflammation pipeline growth.
12. Driving the strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education : Educational Qualifications include MD / MS in Internal and Pulmonary / Critical Care Medicine.

Experience : Minimum 18 years practicing pulmonary clinical medicine, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.

Knowledge and Skills : Expertise in drug development, scientific advocacy, and regulatory affairs.

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