Director / Sr Director - Clinical Development (Pulmonology)

Glenmark Pharmaceuticals; Trento; In loco; EUR 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

A leading pharmaceutical company is seeking a highly experienced clinical development professional to head respiratory drug development. This role involves managing projects, ensuring compliance with regulations, and collaborating with global stakeholders. Candidates should hold an MD or MS with extensive experience in pulmonary medicine and drug development.

Competenze

• Minimum 18 years of experience in pulmonary clinical practice.
• At least 5 years in the pharmaceutical industry or clinical project management.

Mansioni

• Lead and mentor Clinical Sciences respiratory projects.
• Contribute to and review study documents like protocols and consent forms.
• Engage with global regulators and attend safety meetings.

Conoscenze

Drug Development

Scientific advocacy with policymakers/regulators

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, 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. 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 presentations at ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones.
• Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
• Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMPs, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
• Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR related documents, addressing or escalating issues impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review minutes.
• 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.
• Support business development for respiratory programs, portfolio, medical affairs, and lifecycle management, including new programs and expansions.
• Collaborate with internal stakeholders across departments and participate in ad boards, respiratory forums, and meetings. Engage with regulators on development pathways and approval processes.
• Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.

Knowledge and Education:

• Educational Qualifications: MD / MS, with specialization in 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 project management, including regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioral Attributes:

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