Global Clinical Program Lead, Late Respiratory and Immunology Clinical Development

In this capacity, you will supervise a team of Global Development Medical Directors and/or Global Development Scientist Directors, and also work cross functionally to support the design, conduct, monitoring and data interpretation of multiple studies. You will ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally.

You will set the vision and goals against therapeutic area leadership priorities and product strategy; ensure timely decision making; facilitate the balance of cost/time/quality against clinical development objectives; develop relevant risk mitigation strategies; enable quick and effective troubleshooting; represent the program at health authority interactions; review publications aligned to your program; and seek/share findings through your portfolio of studies.

The Global Clinical Program Lead will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.

What you’ll do:

• Clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice
• Scientific medical input to all relevant study documents (including and not limited to protocol, statistical analysis plan, amendments, informed consent, case report forms, safety, and risk-based monitoring plans) to ensure consistency within clinical program and alignment with scientific rationale.
• Scientific medical content at international investigator meetings, and support to local Marketing Companies for country level activities
• Safety surveillance on a study level and/or program level including the process for Adverse Events (AE)/ Serious AE reporting.
• Reviews (with the GCH) the Clinical Study Report and plays key role in preparation and production of relevant sections (Introduction, Results, Discussion).
• Induction and education of new Global Study Team members.
• May also contribute to clinical trial improvement workstreams on behalf of the Clinical function.
• Accountable to GCH and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb, III, IV or Life Cycle Management studies
• Delivery of clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies, and investigators/sites, and provides clarifications as well as solves clinical, scientific, and medical issues in the Global Study Team
• Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams
• Co-leads the study and program strategy for publication development and approval of publications with the GCH
• Line management of project study physicians and scientists

You will need:

• M.D., Ph.D., or equivalent medical or scientific qualification.
• At least 5-8 years of relevant clinical development experience, including study design, protocol development, trial implementation, monitoring, data interpretation, and reporting.
• Experience in clinical development and working within cross-functional teams.
• Knowledge of biostatistics, global regulatory requirements, pharmacovigilance, GCP, and clinical trial safety.
• Strong analytical, problem-solving, teamwork, and influencing skills.
• Excellent written and verbal English communication skills.
• Strong presentation and stakeholder engagement capabilities.
• Ability to work effectively across global teams and travel as required