Global Clinical Program Lead, Immunology

As GCPL in Gastroenterology, you will provide medical and scientific input into programs of small molecules, biologics or cell therapy for clinical stage assets and provide program leadership that is passionate about gastroenterology and clinical immunology. You will take responsibility for clinical development in cross-functional teams to support early to late phase clinical development activities. These include the creation of overall clinical development plans and clinical study design, writing study concepts and protocols, key study and health authority documentation, medical monitoring and ensuring timely delivery of studies.

In this role, you will be:

• Responsible for study design concept delivery
• Responsible for driving clinical and scientific decisions within Global Study Team remits together with other team members
• Accountable for clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice
• Accountable for 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.
• Accountable for scientific medical content at international investigator meetings, and support to local Marketing Companies (MC) for country level activities
• Accountable for 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).
• Accountable for induction and education of new Global Study Team members.
• Work with GCH and TA leadership for identifying risks and proposing mitigation strategies to deliver successful phase IIb, III, IV or Life Cycle Management studies
• Delivering clinical, scientific, and medical information/query responses to Regulatory Agencies, Ethic Committees, Marketing Companies (MCs), and investigators/sites, and provides clarifications as well as solves clinical, scientific, and medical issues in the Global Study Team

Leadership:

• Clinical representative on indication in Global and Clinical Product Teams and/or sub-teams
• Lead governance interactions in conjunction with or as delegated by the GCH such as DRACs, DRCs, PRCs
• Co-lead the study and program strategy for publication development and approval of publications with the GCH
• Line management of project study physicians and scientists

Basic Qualifications

• Medical degree (MD or MD-PhD) required, with specialist training or experience in gastroenterology/gastrointestinal diseases and/or clinical immunology
• Minimum of 5 years in pharma industry, with experience in leading clinical trials to support approval (Phase 2-4)
• Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role
• Experience in leading or reviewing a clinical program to support an indication: design, clinical development plan and Target Product Profile.
• Good presentation skills and effective communication with internal and external collaborators
• Knowledge and experience to work across projects, with a fast-learning curve when moving into new disease areas