Overview
As Global Clinical Program Lead in Late Respiratory and Immunology Clinical Development, you will own a significant portion of an indication-aligned program and lead a cross-functional team to deliver high-quality clinical data. You will shape study strategy, ensure safety and regulatory alignment, and drive publication and stakeholder engagement. You’ll balance cost, time, and quality while advancing a substantial pipeline with an entrepreneurial mindset. This role offers meaningful impact on patients and the organization’s mission to redefine care in respiratory medicine.
Pay / Benefits
- flexible in-office schedule (minimum three days per week in office)
- reasonable adjustments/accommodations
- inclusive and equitable environment
- opportunity to lead high-impact programs
Responsibilities
- Lead design, conduct, monitoring and data interpretation across multiple studies within a clinical program.
- Provide scientific medical input to study documents (protocols, SAPs, amendments, CRFs, safety plans).
- Manage safety surveillance and AE/SAE reporting at study and program levels.
- Prepare and contribute to Clinical Study Reports and related sections.
- Induct and educate new Global Study Team members; contribute to trial improvement workstreams.
- Identify risks and propose mitigations to deliver successful phase IIb/III/IV or lifecycle management studies.
- Deliver responses to Regulatory Agencies, Ethics Committees, Marketing Companies, and investigators.
- Represent the program in indication-level Global and Clinical Product Teams; co-lead publication strategy.
- Line manage project study physicians and scientists.
Key requirements
- MD, PhD, or equivalent medical/scientific qualification
- 5–8 years of relevant clinical development experience
- Experience in study design, protocol development, trial implementation, monitoring, data interpretation and reporting
- Cross-functional collaboration experience
- Knowledge of biostatistics, regulatory requirements, pharmacovigilance, GCP, and trial safety
- Strong analytical, problem-solving, teamwork and influencing skills
- Excellent written and verbal English communication; strong presentation and stakeholder engagement
- Ability to work effectively across global teams and travel as required
- analytical thinking
- teamwork
- influencing
- biostatistics knowledge
- global regulatory requirements
- pharmacovigilance
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