Canada-Based Clinical Development Director, Respiratory

GSK; Mississauga; Remote; CAD 180,000 - 240,000; Full time

Job summary

GSK is seeking a Clinical Development Director to shape the respiratory portfolio in Canada. You will lead the design and delivery of clinical studies, shaping strategies to advance treatments for patients and healthcare providers.

Emphasis on collaboration, clear communication, and problem solving drives the role. The position offers home-based work in Canada (Ontario preferred) with opportunities to influence global teams and regulatory interactions.

Qualifications

• 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 efficient 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.

Responsibilities

• 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
• Providing effective support / oversight of evidence generation activities to assure patient safety and study delivery
• 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

Skills

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

Education

Bachelor’s degree in a science related field

Job description

GSK is seeking a Clinical Development Director to shape the respiratory portfolio in Canada. You will lead the design and delivery of clinical studies, shaping strategies to advance treatments for patients and healthcare providers.

Emphasis on collaboration, clear communication, and problem solving drives the role. The position offers home-based work in Canada (Ontario preferred) with opportunities to influence global teams and regulatory interactions.