Jobs in Genova, United States

Social network you want to login/join with:

col-narrow-left

Other

-

Yes

col-narrow-right

19413656334342553633710

2

08.05.2025

col-wide

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. The role involves discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review and due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.

Job Responsibilities:

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all objectives.
• 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, MMP, and investigator/site lists.
• Provide guidance on subject eligibility, deviations, and 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 documents, addressing data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review minutes.
• Review blinded medical coding for adverse events, prior and concomitant medications, and medical history, participating in BDRM and interpreting efficacy and safety data post-unblinding.
• Support business development for respiratory programs, including lifecycle management and portfolio expansion.
• Collaborate with internal stakeholders across departments and participate in ad boards, forums, and regulatory discussions.
• Drive project development and evaluate new business opportunities, overseeing respiratory program strategies from clinical candidate evaluation to registration.

Knowledge and Education:

Educational Qualifications:

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

Experience:

• Minimum 18 years practicing pulmonary clinical professional experience, with over 5 years in pharmaceutical/clinical development industry, including regulatory interactions.

Knowledge and Skills (Functional / Technical):

• Drug Development
• Scientific advocacy with policymakers/regulators

Behavioural Attributes:

• Strong decision-making and influencing skills; good interpersonal skills.