Senior Director, Clinical Operations Planning And Feasibility

Site Name: GSK House, Belgium-Wavre, Canada

• Ontario

• Mississauga, India

• Karnataka

• Bengaluru, USA - Pennsylvania

• Upper Providence, Warsaw Cirrus

Posted Date: Mar 25 2024

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together.

The Senior Director, Clinical Operations Planning & Feasibility will be responsible for overseeing the successful implementation of end-to-end processes for above study level and study level scenarios creation and feasibility assessment. They will establish a clear and reproducible planning process that integrates frequent updates, eliminates avoidable re-planning, and allows for ease of access to data to execute reliable and Upper Quartile study delivery plans, shifting from reactive to proactive response.

This role will lead and manage a team of Clinical Budget Leads and Clinical Operations Planning & Feasibility Leads who work closely with Clinical Operations Asset Leaders and study teams, including Study Delivery Leads, Clinical Science Leads, Country and Site Activation Leads, GMASE team members and other members of the Development and research unit organizations, as required.

Key Responsibilities:

The responsibilities include but are not limited to the following:

• Lead design, implementation, and management of an industry leading, end-to-end clinical planning process encompassing indication and trial operational feasibility assessment, protocol design & delivery optimization scenario assessment, trade-off options development, design recommendations to reduce protocol complexity, country selection recommendations, and clinical budgeting benchmarks and best practices.

• Manage COPF performance and achievement of strategic and operational objectives, including capacity/demand, speed, quality, effectiveness, and stakeholder satisfaction.

• Implement and manage changes to written standards, training, system and process improvements in relevant areas to ensure we have globally consistent processes that can be replicated across all trials

• Strategically partner with relevant functional areas and participate in transformation initiatives, as needed, to offer Clinical Operations input to program and study design and planning process improvements.

• Apply internal and external data to inform and optimize our study design and trial delivery plan, periodically reviewing effectiveness of data subscriptions and reporting value created from those investments.

• Incorporate Agile methodology to ensure efficient use of resources across GCO, embedding COPF processes in the Study Team Operating Model and evolving, as needed.

• Apply GSK leadership expectations to build and support the COPF team, driving recruitment, performance management, engagement, and career and personal development of team members.

• Stay current on the latest industry trends and best practices, applying technology and data innovations to evolve COPF strategy and service

• Represent the organization at industry events and meetings, building relationships with key stakeholders and partners.

Basic Qualifications

• Bachelor's Degree in Lifesciences/ Business or a related field with applicable experience.

• Significant clinical operations experience preferably across multiple TAs and phases of development in Rx and Vx.

• Strong analytical skills with a data driven approach to planning, implementing and problem solving

• In-depth knowledge of GCP and ICH, drug development process, and other relevant guidelines for clinical research activities

• Significant experience in leading global teams

• Exceptional project management skills

• Ability to establish and build internal and external relationships at all levels in a highly dynamic and matrixed environment

• Highly developed communication skills appropriate to the target audience

• Accomplished influencing and stakeholder management skills

Preferred Qualifications

• Advanced Degree in Lifesciences/ Business or a related field with applicable experience

• Ability to drive and influence strategic direction.

• Exceptional capability to influence leadership.

• Experience working independently with senior executives and the ability to quickly build personal credibility and assimilate business issues/need.

• Demonstrated skill operating in situations characterized by complexity, ambiguity and high levels of uncertainty.

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.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

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