Director / Sr Director - Clinical Development (Pulmonology)

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

Descrizione del lavoro

A leading pharmaceutical company seeks a Medical Monitor to oversee respiratory projects and engage with global regulatory bodies. The ideal candidate will have extensive experience in pulmonary medicine, drug development, and regulatory discussions, aimed at expediting drug approvals and ensuring safety in clinical trials.

Competenze

• Minimum 18 years as a practicing pulmonary clinical professional.
• Over 5 years in the pharmaceutical industry or clinical projects.
• Experience involving drug development and regulatory interactions.

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review and contribute to clinical study documents and protocols.
• Engage with global regulators on clinical development pathways.

Conoscenze

Expertise in drug development

Scientific advocacy

Engagement with policymakers

Decision-making skills

Interpersonal abilities

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. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals; review and due diligence of in-licensing respiratory molecules; and presentations at ad boards and global respiratory meetings.

Job Responsibilities: Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all objectives. The responsibilities of the Medical Monitor may 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, MMPs, and investigator/site lists for vendor selection.
3. Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, 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. Participating in internal or joint CRO-sponsor medical safety meetings and reviewing medical meeting minutes.
6. Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM prior to database lock, and interpreting efficacy and safety data after unblinding.
7. Supporting business development for respiratory programs, including new and lifecycle management programs, and collaborating with internal stakeholders across departments.
8. Participating in ad boards, respiratory forums, and meetings; engaging with regulators on clinical pathways and approval processes.
9. Developing projects and evaluating new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline.
10. Driving the strategy and delivery of respiratory programs from candidate evaluation to registration.

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

Experience: Minimum 18 years 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.