Clinical and Epidemiology Excellence Lead

Senior Clinical and Epidemiology Research and Development Excellence Lead (CEEL)

The Senior CEEL is responsible for supporting the Head Clinical RDC in:

• Defining operational strategy for implementation of projects assigned to the RDC
• Tracking of milestones, KPIs and deliverables to manage the performance of Clinical R&D with the RDC
• Support oversight of Clinical R&D budget within the RDC to help make decisions about prioritization and trade-offs
• Support of risk management, including issues with may be specific to a given RDC
• Support outsourcing and contracting to meet needs of RDC
• Assistance with recruiting and onboarding of new Clinical R&D staff
• Management of process improvements, auditinspection preparation and CAPAs

Your responsibilities:

• Maintain overall oversight on Clinical RDC budget, providing regular estimates and updates to Head Clinical RDC. Updates to the Clinical and Epi Project Leads will be provided in collaboration with the appropriate PDL.
• Plan resource allocation within Clinical RDC; ensure that clinical teams are appropriately staffed, work with Clinical and Epi Project Leads on headcount requests. Drive recruitment activities in the Clinical RDC (in close collaboration with HR): request for positions (including replacements), job profile updates, screening of candidates, set up of interviews, collection of feedback, decision, support with offer letters
• Plan, coordinate and execute training and mentoring of Clinical RDC newcomers
• Track milestones on projects, KPIs and deliverables for Clinical RDC to optimize RDC performance. Support risk management for Clinical RDC.
• Contribute to development of standards and processes across Clinical RDC. Ensure that standards and processes are implemented globally throughout the Clinical RDC with a high level of compliance and quality.
• Track implementation of CAPAs assigned to Clinical RDC staff; coordinate and contribute to audits and inspections as appropriate
• Where appropriate, lead large process improvement andor change management work streams, including cross-functional work streams, particularly when specific to a given RDC. Participate as core member in Steering Committees as appropriate, including the Performance Update Committee (PUC) and the Issue Management Core Team (IMCT).
• Liaison with relevant stakeholders, including but not limited to Clinical Evidence Generation (CEG), Portfolio Integration and Operation (PIO), Regulatory Affairs (RA) Medical Platform, etc
• If applicable, supervise additional Business Excellence staff including contractors/consultants as assigned to supervise the performance and ensure the activities are completed as per the plan
• Participate to Clinical RDC Leadership Team and track key deliverables

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BA or BS degree from an accredited university, with a degree in a life science field a considerable asset.
• Previous experience in the field of clinical research, GCP, project management is an asset.
• Strong project management skills
• At least 5 years of work experience in vaccine clinical research or related field
• Excellent people and team management skills.
• Strategic thinking skills and achievement oriented.
• Excellent knowledge of spoken and written English.

Preferred Qualifications:

If you have the following characteristics it would be a plus:

• Master degree or equivalent education, preferably in a science or health related discipline

Or

• Post graduate degree in a life science field
• Previous experience in the field of vaccinology
• Solid understanding of clinical and/or epidemiological trial design, trial execution and operations
• Understand business implication of trial design and execution
• Experience in resource and budget management

• Li-GSK

Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork in a culture of Innovation, Performance and Trust.

GSK Vaccines– Our Vaccines business is one of the largest in the world, developing, producing and distributing over 2.5 million vaccines every day to people across 170 countries. For further information, please visitwww.gsk.com.

Our department:

Patient-focused Research and Development (R&D) is the heart of our business. GSK has a strong history and expertise in vaccines, and we are staying at the forefront of innovation in this field.

For many years, vaccines have been used mainly to prevent diseases caused by infections, mostly in infants and children. Today, we are focused on developing vaccines for all stages of life, and we believe vaccines can also be used successfully to treat diseases and be therapeutic.

These innovation trends have a strong impact on what we do in Research and Development. We take the best science, with the most impactful technologies and combine it with our GSK culture. Next to our existing portfolio of prophylactic vaccines and moving into the field of therapeutic vaccines, our R&D programme focuses on vaccines for diseases such as RSV, COPD and Meningitis. Another part of R&D targets diseases particularly prevalent in the developing world, including the World Health Organisation’s priority diseases - tuberculosis and malaria.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

We provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best.

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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