Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Cremona; In loco; EUR 100.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Head to lead innovative drug development for respiratory diseases. This role encompasses oversight of clinical studies, regulatory discussions, and business development, requiring extensive industry experience and medical expertise.

Competenze

• MD/MS in Internal and Pulmonary/Critical Care Medicine is mandatory.
• Minimum 18 years of experience in pulmonary clinical practice, with over 5 years in the pharmaceutical industry.
• Strong decision-making and influencing skills.

Mansioni

• Lead and mentor clinical projects ensuring timely delivery.
• Engage with regulators on clinical pathways and drug approvals.
• Review key clinical study documents and monitor data safety.

Conoscenze

Drug development

Scientific advocacy

Regulatory engagement

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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, involving 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 includes 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 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, escalating any data impacting safety or study integrity.
6. Attend internal or joint CRO-sponsor 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 management, and lifecycle 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 approval processes.
11. Develop projects and evaluate new business opportunities or internal Target Drug Candidates for pipeline expansion and growth, overseeing respiratory programs from evaluation to registration.

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

Experience: Minimum 18 years practicing pulmonary clinical professional with over 5 years in the pharmaceutical industry, clinical development projects, and regulatory interactions.

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

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