Note: Incumbent can be based anywhere in Europe or the US.
Role Overview:
This position is intended to lead 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 hoc boards and global respiratory meetings.
Job Responsibilities:
* Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all milestones. Responsibilities include but are not limited to:
* Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
* Reviewing CRO medical monitoring capabilities during study startup and RFP processes, including CVs, MMPs, and investigator/site lists for vendor selection.
* Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.
* 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.
* Participating in internal or joint CRO-sponsor safety meetings and reviewing meeting minutes.
* Reviewing blinded medical coding for adverse events, serious adverse events, medications, and medical history, participating in BDRM prior to database lock, and interpreting efficacy and safety data post-unblinding.
* Supporting business development for respiratory programs and portfolio, including medical affairs, BD, and ROW development, as well as new and lifecycle management programs.
* Building and maintaining collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, Legal, etc.), participating in ad boards, respiratory forums, and meetings, and engaging with regulators on development pathways and approval processes.
* Developing projects and evaluating new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline and business growth. Driving the strategy and delivery of respiratory programs from candidate evaluation to registration.
Knowledge and Education:
Educational Qualifications:
o MD / MS
o MD in Internal and Pulmonary / Critical Care Medicine
Experience:
o Minimum 18 years of experience as a practicing pulmonary clinical professional, with more than 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions for drug development.
Knowledge and Skills (Functional / Technical):
o Drug Development
o Scientific advocacy with policymakers / regulators
Behavioral Attributes:
o Strong decision-making and influencing skills. Good interpersonal skills are essential.
Location: Director Development, Frosinone, Italia
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