Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Bolzano; In loco; EUR 100.000 - 150.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a highly qualified individual to lead clinical development in respiratory medicine. The role involves extensive collaboration with stakeholders, regulatory authorities, and overseeing the entire clinical development process. Candidates must possess significant experience in pulmonary medicine and a strong background in the pharmaceutical industry.

Competenze

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

Mansioni

• Lead and manage Clinical Sciences respiratory projects.
• Review key study-related documents and medical monitoring capabilities.
• Interact with global regulators for drug approvals and oversee safety data.

Conoscenze

Drug Development

Scientific advocacy with policymakers / regulators

Formazione

MD / MS

MD Internal and Pulmonary / Critical Care Medicine

Descrizione del lavoro

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, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and align them with the company's business objectives. Discussions with global regulators on respiratory clinical development pathways for facilitation of drug approvals;
• Review & due diligence of in-licensing respiratory molecules;
• Presentations in ad boards and global respiratory meetings.

Job Responsibilities :

• Lead, manage and mentor Clinical Sciences respiratory projects and ensure timely delivery of all deliverables. Responsibilities may include but are not limited to:
• Contribute to and review key study-related documents such as protocols, informed consents and amendments, eCRFs, SAP, MMP, SMP, and TLFs;
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CRO MM CVs, MMP, and investigator/site lists for vendor selection;
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams;
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, addressing or escalating data impacting safety or study integrity;
• Attend internal or joint CRO-sponsor medical monitoring safety meetings and review meeting minutes;
• Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding;
• Support business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, and lifecycle management programs;
• Build and maintain collaboration with internal stakeholders across departments, participate in ad boards, forums, and presentations, and engage with regulators on development pathways;
• Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand respiratory, allergy, and inflammation pipeline and business growth, from candidate evaluation to registration.

Knowledge and Education :

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

Experience :

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

Knowledge and Skills (Functional / Technical) :

• Drug Development
• Scientific advocacy with policymakers / regulators

Behavioral Attributes :

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