Director / Sr Director - Clinical Development (Pulmonology)

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 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 advisory boards and global respiratory meetings.

Job Responsibilities : Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones. The responsibilities include but are not limited to:

1. Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.
2. Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CRO MM CVs, MMP, investigator/site lists for vendor selection.
3. Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.
4. Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, escalating issues impacting safety or study integrity.
5. Attending internal or joint CRO-sponsor safety meetings and reviewing medical meeting minutes.
6. Reviewing blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM, and interpreting efficacy and safety data post-unblinding.
7. Supporting business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new and lifecycle management programs.
8. Building collaborative relationships with internal stakeholders across preclinical research, toxicology, DMPK, regulatory, ClinOps, project management, medical affairs, legal, and others.
9. Participating in advisory boards, respiratory forums, and presentations at respiratory meetings.
10. Engaging with regulators on clinical development pathways and facilitating faster approvals.
11. Developing projects and evaluating new business opportunities or internal target drug candidates for expanding the respiratory, allergy, and inflammation pipeline and business growth.
12. Driving the overall strategy and delivery of respiratory programs from candidate evaluation to registration.

Knowledge and Education : Educational Qualifications : MD / MS in Internal and Pulmonary / Critical Care Medicine.

Experience : Minimum 18 years of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical projects involving drug development and regulatory interactions.

Knowledge and Skills : Expertise in drug development, scientific advocacy with policymakers/regulators.

Behavioral Attributes : Strong decision-making and influencing skills, with good interpersonal skills.