Clinical Development Director

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 company's business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals.
• Review & due diligence of in-licensing respiratory molecules.

Presentation in ad boards and global respiratory meetings.

Job Responsibilities :

• Lead, manage, and mentor Clinical Sciences respiratory projects ensuring timely delivery of all milestones. Responsibilities may include, but are not limited to:
• 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, 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 SAE or SUSAR documents, addressing any data impacting subject safety or study integrity.
• Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.
• Review blinded medical coding for AEs, SAEs, medications, and medical history; participate in BDRM before DBL and interpret efficacy and safety post-unblinding.
• Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including lifecycle management programs.
• Build and maintain collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, legal, others). 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 Target Drug Candidates to expand respiratory, allergy, and inflammation pipeline and business growth. Drive strategy and delivery 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.
• At least 5 years in the pharmaceutical industry or clinical projects in drug development, 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.