Manager Clinical Pharmacology Modeling and Simulation (Oncology)

Does managing a team and overseeing the systems support work related to studies in the general toxicology area and others mandated by the FDA excite you ? If so, this could be the perfect fit for your career.

As Pharmacokinetics Manager you will mange the Standard for Exchange of Nonclinical Data (SEND) submission process requires for all general toxicology and forthcoming safety related studies. You will also oversee computer system validation staff in the systems, studies, and quality group.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Manage the staff and processes for submission of SEND files from in-house and CRO conducted studies and the provision of all SEND files for Regulatory Submissions
• Engage with FDA regulatory groups who oversee and support SEND submissions to keep GSK compliant with the current scope of SEND and to prepare for additional study types in the future
• Manage the Computer System Validation staff and processes for validating and maintaining all IVIVT applications and systems that are used in the laboratory and scientific computing areas
• Maintain the compliant state of the scientific equipment and applications that are subject to inspection by regulatory agencies
• Oversee the systems management staff to ensure all analytical instrumentation is maintained in a state of readiness and can be used for analyses that support the portfolio
• Provide project management support and expectations of deliverables for all staff and act as the site lead for SSQ
• Manage reporting (metrics, KPIs) of staff performance and deliverables in the form of dashboards

Why you?

Basic Qualifications:

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

• Bachelor's Degree

Preferred Qualifications:

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

• Experience in performing and managing computer system validation activities and maintain the compliant state for scientific applications and systems that are subject to inspection by regulatory agencies
• Deep understanding of Toxicology studies
• Understanding of the SEND submission process and experience with the SEND committees
• Experience engaging different departments and stakeholders

Why 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. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
• Managing individual and team performance.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Implementing change initiatives and leading change.
• Sustaining energy and well-being, building resilience in teams.
• Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
• Developing people and building a talent pipeline.
• Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
• Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
• Budgeting and forecasting, commercial and financial acumen.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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 organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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