Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Treviso; Remoto; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Lead to oversee the clinical development of innovative respiratory drugs. This role involves managing clinical projects, collaborating with global regulators, and supporting business development initiatives. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in drug development.

Competenze

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

Mansioni

• Lead, manage, and mentor Clinical Sciences respiratory projects.
• Engage in discussions with regulators on clinical development pathways.
• Drive the strategy and delivery of respiratory programs.

Conoscenze

Drug development expertise

Scientific advocacy

Strong decision-making

Interpersonal skills

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, 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 & 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. Review key study-related 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 any data 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 prior to DBL; interpret efficacy and safety after unblinding.
8. Support business development for respiratory programs and portfolio, including new and lifecycle management programs.
9. Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings.
10. Engage in discussions with regulators on clinical development pathways and faster approvals.
11. Develop projects and evaluate new business opportunities or internal Target Drug Candidates for pipeline expansion and growth.
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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical project development, including regulatory interactions.

Knowledge and Skills (Functional / Technical):

Drug development expertise and scientific advocacy with policymakers/regulators.

Behavioral Attributes:

Strong decision-making and influencing skills, along with good interpersonal skills.