Senior Clinical Development Leader
About the Role:
This position plays a critical role in leading and supporting the clinical development of new drugs. The ideal candidate will be responsible for planning, coordinating, and executing clinical studies to ensure timely delivery of all deliverables.
* Lead clinical sciences respiratory projects and oversee the entire development process from conception to registration.
* Collaborate with global regulators to facilitate drug approvals and discuss respiratory clinical development pathways.
* Conduct due diligence on in-licensing respiratory molecules and present at internal and external meetings.
Key Responsibilities:
1. Manage and mentor clinical project teams, ensuring timely completion of tasks and deliverables.
2. Review and contribute to key study documents, including protocols, informed consents, and amendments.
3. Assess CRO medical monitoring capabilities and provide guidance on subject eligibility, deviations, and protocol-related questions.
4. Analyze blinded efficacy and safety data, identifying potential issues that may impact subject safety or study integrity.
5. Participate in internal and joint CRO-sponsor medical monitoring safety meetings and review meeting minutes.
6. Develop and maintain close collaboration with internal stakeholders, including Preclinical Research, Toxicology, Regulatory, ClinOps, Project Management, Medical Affairs, and others.
7. Evaluate new business opportunities and internal Target Drug Candidates for expansion of respiratory, allergy, and inflammation pipeline and business growth.
Requirements:
* Minimum 18 years of experience as a practicing pulmonary clinical professional, with >5 years in the pharmaceutical industry or clinical projects in clinical development.
* MD/MS or MD Internal and Pulmonary/Critical Care Medicine degree.
* Excellent decision-making and influencing skills, with good interpersonal skills.
What We Offer:
A dynamic work environment with opportunities for career growth and professional development. A team-oriented culture with a focus on delivering high-quality results.