Business Introduction At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D; focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re looking for a Clinical Development Director to shape the future of our respiratory portfolio. In this role, you’ll lead the scientific design and delivery of clinical studies across multiple stages of drug development and play a pivotal part in driving our clinical research and development strategy. You will lead the clinical development of respiratory disease programs, working closely with global teams to design and deliver impactful clinical studies. Your role will help shape operational strategies that advance important treatments, supporting patients and healthcare providers. This position offers a unique chance to grow your expertise, make meaningful contributions, and be part of our mission: uniting science, technology, and talent to get ahead of disease together. Generating the data and evidence required to determine a medicine’s potential efficacy, safety profile, key areas of product differentiation and value to patient in the shortest possible timeframe Contributing to regulatory interactions including clinical trial applications, briefing documents, presentations, addressing questions and responses Contributing to the writing of the clinical study synopsis (CSP), study protocols, clinical study reports (CSR)



and any subsequent study abstract and manuscript publications Supporting the strategic management of the Integrated Evidence Plan (IEP), including the Clinical Development Plan (CDP) for an asset in development Ensuring alignment with and support to project strategic plans, regulatory requirements and commercial goals, optimizing clinical study design aligned with IEP and CDP Delivering clinical development timelines, enabling key decision points and Go/No Go criteria for the CDP Developing and maintaining relationships with matrix counterparts in Commercial, Research, Regulatory, Clinical Operations and Statistics. Serving as a clinical point of contact for senior management and senior level matrix teams, both internally and externally for an asset in development Interfacing and influencing a diverse range of scientific external experts (e.g. regulators, payors, CROs, consultants, investigators) in order to deliver clinical programs and align to business strategy and address patient needs Contributing to the implementation and embedding of strategic initiatives and various organizational initiatives in Clinical Sciences Identifying and highlighting transformational opportunities where projects can offer highly significant benefit to patients in ways not possible with existing approaches Bachelor’s degree in a science related field ~3 years of Significant clinical training and/or applicable clinical research experience; understanding of clinical development planning and running clinical trial from concept study idea to publication. ~ Robust knowledge of ICH guidelines, GCP, FDA requirements, regulatory and reimbursement data requirements in responsible area ~ Solid understanding of needs and priorities of regulators, payers and prescribers in relevant market(s) ~ Demonstrated experience using new learning and digital tools to create innovation in other areas ~ Thorough understanding of clinical research methodology and biostatistics principles, to facilitate innovative and effective clinical trial design, and clinical development plans with clear data-driven decision rules ~ Proven ability to utilize statistics, and visualisation techniques to interpret or analyse complex information and make correct inferences and conclusions. PhD or PharmD degree valuable but not required Experience leading matrix teams with a strong reputation of inspiring and motivating high performance Significant experience in respiratory clinical drug development with an understanding of the disease area, the underlying biology and potential therapeutic targets. This role is home based in Canada, preferably in Ontario. Are you ready to bring your clinical development experience to a team that’s making a real impact? Analytical Thinking, Business Acumen, Change Management, Clinical Research, Clinical Trial Designs, Communication, Decision Making, Fostering Collaboration, Influencing Without Authority, Leadership, Matrix Leadership, Mentorship, People Management, Risk Management, Strategic Thinking We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successf

📌 Clinical Development Director, Respiratory Diseases (Calgary)
🏢 GSK
📍 Calgary