Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Cuneo; In loco; EUR 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a Clinical Development Leader to manage the clinical development of innovative drug candidates in respiratory medicine. This pivotal role requires extensive expertise, strong leadership, and regulatory engagement skills to drive projects from inception to approval, ensuring alignment with business objectives.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or drug development.
• Expertise in enabling clinical approvals and working with stakeholders.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contributing to key study documents and reviewing CRO capabilities.
• Participating in regulatory discussions for drug approvals.

Conoscenze

Drug Development

Scientific Advocacy

Engagement with Policymakers

Regulatory Interactions

Decision Making

Interpersonal Skills

Formazione

MD / MS in Internal Medicine, Pulmonary, or 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 aligned 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 : Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones. 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 startup 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 queries 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 issues impacting subject safety or study integrity.
5. Participating in internal or joint CRO-sponsor 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, including new and lifecycle management projects, and building collaborations with internal stakeholders such as Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Medical Affairs, and Legal.
8. Participating in ad boards, respiratory forums, and meetings, and engaging with regulators on clinical development pathways for faster approvals.
9. Evaluating new business opportunities and internal drug candidates to expand the respiratory, allergy, and inflammation pipeline.
10. Driving strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education : 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 : Expertise in drug development, scientific advocacy, and engagement with policymakers and regulators.

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