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SalaryPosted Date: Mar 4 2024
Position Summary
The Senior Director, Clinical Project Lead (CPL) leads the Clinical Development Program(s) for one asset or a portfolio of assets. The CPL provides integrated and innovative clinical development strategy to support the creation and management of the Integrated Evidence Plan (IEP). The CPL is accountable for the development, execution, and oversight of Phase I through IV clinical studies, including the integration of global considerations into strategic decisions. The CPL ensures alignment of the Clinical Development Plan (CDP) with the overall Assent Plan, and overall strategic product development. The CPL works in collaboration with the Vaccine Clinical Science Cluster Head to ensure high scientific rigor and quality of design in clinical studies. The CPL ensures the incorporation of regional input into global CDPs. The CPL ensures the protocols, reports, publications, and clinical regulatory documents are of highest scientific, operational, and ethical standards and are completed in time and on budget. The CPL collaborates with Quality and Compliance to ensure high quality execution of the CDP. The CPL is accountable for the medical and human safety aspects of the clinical programs.
Key Responsibilities
- 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 Vaccines 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 as 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 & Expertise
Basic Qualifications
- Medical Doctor.
- Specialisation in the field of paediatrics, obestrics, gynaecology, infectious diseases, clinical epidemiology, or pharmacoepidemiology.
- Experience conducting clinical research independently.
- Work experience in vaccine clinical research within industry.
- Experience in translational science and biomedical research regulation, including ICH and GCP.
- People and team management experience.
- Fluent in spoken and written English.
Preferred Qualifications
- PhD.
- Experience in clinical vaccinology.
- License to practice medicine and board and/or professional certification.
- Knowledge and understanding of causes of infectious diseases, health interventions and the global public health landscape.
- Proven track record of managing complex programmes.
- Sensitivity to the needs of a diversified ethnic groups and ability to build rapport across the spectrum.
- Strategic thinking skills and achievement oriented.
- Ability to critically analyse information, identify strengths and weaknesses of approaches and develop remedial actions to mitigate risks.
- Ability to understand high level corporate and business objectives: rapid, flexible, innovative working and decision making.
- Executive capability with strategic planning and budget processes such as analytical thinking.
- Strong leadership, coalition-building, and communication skills.
Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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