Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Plasencia; In loco; EUR 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company seeks a Clinical Development Lead to oversee the clinical development of new respiratory drugs. This role involves strategic leadership in drug development, regulatory engagement, and collaboration with various stakeholders to ensure successful project delivery. Ideal candidates will have extensive experience in pulmonary medicine and a proven track record in the pharmaceutical industry.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Contribute to and review key study-related documents.
• Engage with regulators on clinical development pathways.

Conoscenze

Drug development

Scientific advocacy

Decision-making

Interpersonal skills

Formazione

MD / MS in Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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 and 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 to ensure timely delivery of all deliverables.
2. Contribute to and 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 medical monitors, site investigators, and study teams.
5. Review blinded efficacy and safety data, including listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating 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 database lock, and interpret efficacy and safety data post-unblinding.
8. Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management programs.
9. Collaborate with internal stakeholders across various departments.
10. Participate in ad boards, respiratory forums, and presentations at respiratory meetings.
11. Engage with regulators on clinical development pathways for faster approvals.
12. Evaluate new business opportunities and internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline.
13. Drive the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education

Educational Qualifications: MD / MS (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 projects in drug development, including regulatory interactions.

Knowledge and Skills

Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes

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