Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; München; Vor Ort; EUR 120.000 - 180.000; Vollzeit

Zusammenfassung

A leading pharmaceutical company seeks a Head for Clinical Development to oversee innovative drug development processes in respiratory medicine. The role requires strong leadership skills, extensive experience in pulmonary medicine, and a strategic approach to regulatory interactions. You'll work closely with global regulators and internal teams to ensure successful drug approvals.

Qualifikationen

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

Aufgaben

• Lead Clinical Sciences respiratory projects ensuring timely delivery of milestones.
• Review key study documents like protocols, informed consents, and amendments.
• Collaborate with stakeholders in respiratory, allergy, and inflammation pipeline.

Kenntnisse

Drug Development

Scientific advocacy

Ausbildung

MD / MS

MD in Internal and Pulmonary / Critical Care Medicine

Jobbeschreibung

Pls 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review & due diligence of in-licensing respiratory molecules, and representation in advisory boards and global respiratory meetings.

Job Responsibilities :

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones.
• Review and contribute to key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Assess CRO medical monitoring capabilities during study startup and RFP processes, including review of CVs, MMP, and investigator/site lists for vendor selection.
• Guide on subject eligibility, deviations, and other medical, safety, or protocol-related queries to CRO MM, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, escalating issues impacting safety or study integrity.
• Participate in internal or joint CRO-sponsor medical safety meetings and review minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.
• Support business development for respiratory programs, portfolio, medical affairs, BD, and ROW development, including new and lifecycle management programs.
• Collaborate with internal stakeholders (Preclinical, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, Legal) and participate in ad boards, forums, and regulatory discussions.
• Evaluate new business opportunities and internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from clinical candidate selection to registration.

Knowledge and Education :

Educational Qualifications :

• MD / MS
• MD in Internal and Pulmonary / Critical Care Medicine

Experience :

• Minimum 18 years of experience as a practicing pulmonary clinical professional.
• At least 5 years in the pharmaceutical industry or clinical development projects, including regulatory interactions.

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers and regulators

Behavioral Attributes :

• Strong decision-making and influencing skills.
• Good interpersonal skills.