GLOBAL CLINICAL PROGRAM LEAD

Make a more important contribution. Impact patients’ lives every day. Contribute to our growing pipeline.Join a place with the commitment, knowledge and backing from the business to continue expanding our pipeline. With one of the broadest and deepest pipelines, we are determined to keep chipping in and pushing forward. When we get it right there’s nothing more motivating. ? AZ’s vision is to grow and expand the indications and assets in respiratory and or immunology to become a major player in the field. This Global Clinical Program Lead (GCPL) role in Late stage clinical development in R&I is designed to help deliver on that ambition.What you will do: GCPL is responsible for the design, conduct, monitoring, data interpretation and reporting of respiratory and immunology clinical trials within the program to ensure clinical data collected allow to assess the benefits and risks of the compound, as aligned with overall clinical development program strategy globally, including indications. You will ensure studies are operated according to the highest scientific and ethical standards and in compliance with internal SOPs, local regulations, GCP and regulatory requirements. The GCPL will be able to deputize for Global Clinical Head (GCH) and lead independently on development activities of the clinical development plan. Typical Accountabilities: Is responsible for study design concept delivery Is responsible for driving clinical and scientific decisions within Global Study Team remits together with other team members Is charged with clinical, scientific, and ethical components of studies including patient safety on a study and/or program level in compliance with Good Clinical Practice Is accountable for scientific medical input to all relevant study documents (including but 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. You will be responsible for scientific medical content at international investigator meetings, and support local Marketing Companies (MC) for country-level activities Is 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 a key role in the preparation and production of relevant sections (Introduction, Results, Discussion). Is accountable for the induction and education of new Global Study Team members. May also contribute to clinical trial improvement workstreams on behalf of the Clinical function. May be accountable to GCH (or delegate) 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 (MCs), 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 Leads governance interactions in conjunction with or as delegated by the GCH such as DRACs, DRCs, PRCs 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  Regulatory Interactions:? Plays a key role in the development of the clinical sections of regulatory submission documents and is accountable to GCH for their content Provides a leadership role in writing responses to comments/questions of Regulatory Authorities for clinical modules Leads as delegated by GCH the strategy for the development of regulatory agency briefing documents (BD) and ensures BD completeness; defends BD positions during regulatory meetings as delegated by GCH  Scientific Medical & Analytical Accountabilities: Stays up to date with relevant scientific literature, and can message key impactful points, as applicable Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation Scientific/medical expertise for the Product Team, in analyses and interpretation of trial data. Messaging and external impact accountabilities Maintains a high degree of understanding and awareness of new and emerging medical development advances in the relevant therapeutic area globally. Builds trustworthy relationships with steering committees/executive committees, academic research organizations and clinical research organizations as applicable Works with international colleagues and external Alliance partners on development initiatives and regulatory issues Provides guidance for externally sponsored trials in cooperation with regional MCs  People Management: 5-8 direct reports Basic Qualifications An MD, MBBS, or other equivalent medical degree from an accredited university Board certification in pulmonary medicine Experience in matrix team environment with interplay between clinical, commercial, drug safety and regulatory Minimum of 5 yrs experience in pharma industry, clinical or academic setting with experience in leading late phase clinical trials to support approval Knowledge of biostatistics, global regulatory environment, and pharmacovigilance relevant to the role Experience in leading a clinical program to support an indication: design, clinical development plan and Target Product Profile Experience in writing clinical aspects of briefing documents for regulatory interactions  Plays a critical role in writing sections of a submission dossier Good presentation skills and effective communication with internal and external collaborators Knowledge and experience working across projects, with a fast-learning curve when moving into new disease areas Line management experience Behaviors Required of this Role: Demonstrated leadership qualities with focus on collaborative working skills, trust, and openness, irrespective of cultural setting Proven teamwork and collaboration skills Demonstrates AstraZeneca Values and Behaviors This role is placed at our dynamic R&D site in Boston, Seaport Boulevard, MA, US. As AstraZeneca continues to put patients at the forefront of our mission, we are excited for our move to Kendall Square/Cambridge in 2026.? Find out more information here:? ?Kendall Square Press Release When we put unexpected teams in the same room, we unleash ambitious thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of four days per week from the office. But that doesn’t mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.? Date Posted14-Oct-2024Closing Date25-Oct-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.SummaryLocation: US - Boston - MAType: Full time