Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company is seeking an experienced Head of Clinical Development for respiratory drug projects. This role involves overseeing clinical studies, engaging with global regulators for approvals, and reviewing study documentation. The ideal candidate will have extensive experience in pulmonary medicine and a strong background in drug development, making significant contributions to the company's innovative programs.

Competenze

• Minimum 18 years in pulmonary clinical practice.
• 5+ years in pharmaceutical industry or drug development.
• Expertise in engaging with regulators.

Mansioni

• Lead and manage clinical respiratory projects.
• Contribute to and review key study documents.
• Engage with global regulators on clinical development.

Conoscenze

Drug development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal Medicine

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 and 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 participation in advisory boards and global respiratory meetings.

Job Responsibilities: Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all deliverables. Responsibilities include but are not limited to:

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 for vendor selection.
3. Providing guidance on subject eligibility, deviations, and other medical or safety-related questions to CRO medical monitors, 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 subject safety or study integrity.
5. Attending internal or joint CRO-sponsor safety meetings and reviewing medical meeting minutes.
6. Reviewing blinded medical coding for adverse events, concomitant medications, and medical history, and participating in BDRM prior to database lock, providing primary interpretation post-unblinding.
7. Supporting business development for respiratory programs, portfolio, medical affairs, and lifecycle management including new programs.
8. Building and maintaining collaboration with internal stakeholders across departments.
9. Participating in advisory boards, respiratory forums, and presentations at respiratory meetings.
10. Engaging with regulators on clinical development pathways for faster approvals.
11. Developing projects and evaluating new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline.
12. Driving the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education: Educational Qualifications: MD / MS in Internal Medicine, Pulmonary, or 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 projects involving drug development and regulatory interactions.

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

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