Senior Director, Clinical Project Lead (CPL) - Early Development

Senior Director, Clinical Project Lead (CPL) – Early Discovery

POSITION SUMMARY

The Senior Director, Clinical Project Lead (CPL), Early Development focuses mostly on early phases of development and is also involved in the early conception of long-term Phase I to IV Clinical Development activities within a group of early discovery programs and task forces within the Discovery Product Unit.

The CPL, Early Development is accountable for the development, execution, and oversight of Phase I or I/II clinical studies, including the integration of global considerations into strategic decisions.

The CPL, Early Development works with a cross functional team to create high level development plans for early assets in the vaccines pipeline.

KEY RESPONSIBILITIES IN DETAIL

• Manages the team of Clinical Science Leads (CSLs) and Senior Clinical Science Leads (SCSLs), assigned to the development program, who lead the clinical matrix teams responsible for clinical study activities, including study design, protocol development, input into statistical analysis plans, medical data cleaning and reconciliation, data analysis and interpretation, in compliance with Good Clinical Practice (GCP) and GSK policies and procedures.
• Accountable for the study design and serves as the Clinical Sponsor Signatory for the protocol.
• Accountable for the final analysis and interpretation of clinical trial data and serves as the Clinical Sponsor Signatory for the clinical study report.
• Serves as the primary point of contact for clinical with the Principal Investigators (PIs).
• Accountable for the authorship and approval of clinical documents for regulatory submissions, including Clinical Expert Statements, and serves as the Program Clinical Expert for input into regulatory documents/meetings.
• Accountable to ensure disclosure and publication of clinical trial data according to ICJME and relevant GSK policies and guidelines.
• Supports cross-functional partners as necessary for activities including External Expert (EE) engagement and PI selection. Supports the regional Medical Affairs teams as needed.
• Drives the end-to-end integrated clinical development strategy that is appropriately resourced to achieve regulatory approvals, reimbursable/recommended vaccines, and successful life cycle management. Accountable for consistently achieving project timelines in global programs with high quality of execution. Participates in key budget/forecast activities in collaboration with Vx Clinical Science Excellence Lead, and Clinical Operations Asset Lead to ensure milestones realisation and resource optimisation.
• Champions implementation of innovative methods and processes within clinical plans, encourages others to think differently and come up with business solutions.
• Establishes expeditious clinical development timelines, incorporating key decision points and Go/No Go criteria in CDP.
• Strategic Leadership: Integrates scientific rationale, regulatory requirements, product development plan and commercial goals to optimise clinical study designs aligned with the IEP and CDP.
• Represents the Clinical Science function at the Vaccine Development Team (VDT), Vaccine Commercialisation Team (VCT), and Discovery Project Team (DPT), as applicable. Supports the VDT/VCT/DPT as necessary through provision of thoughtful senior clinical input and technical expertise to global development questions, including contributions to internal and external briefing documents and presentation materials. Serves the primary clinical voice for the project at governing bodies such as Development Review Board (DRB) Research Review Board (RRB) and technical committees such as Global Safety Board (GSB), Protocol Review Board (PRB) and Toxicology Working Group (TWG).
• Collaborates with cross-functional partners in Preclinical, Technical Development, Global Clinical Operations, Biostatistics, Regulatory Affairs, Medical Affairs, Commercial, Value Evidence and Outcomes, Safety, etc. to ensure effective delivery of the project according to agreed plans.
• If requested, involved in the development and execution of external collaborations. May be requested to support business development activities, including the performance of due diligence reviews.
• Plays an active role in the technical and leadership development of Clinical Sciences staff and maintains oversight and strategic intent of the program. Ensures effective coaching and mentorship of more junior members of the clinical team.
• Core member of the Vaccines Clinical Science Cluster Leadership Team.

CANDIDATE PROFILE – QUALIFICATIONS AND EXPERTISE

Basic Qualifications

• MD with experience conducting clinical research independently.
• Industry experience in vaccine clinical research, or related field (e.g., infectious diseases, immunology