• Job Description

  Req#: 386022

  Head of Clinical Operations; Poland and CEE (Central Eastern Europe)

  GSK’s 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.

  The Head of Clinical Operations Poland and CEE (Central Eastern Europe) will be accountable for the effective quality performance and delivery of both Rx and Vx sponsored clinical trials across all therapy areas and development phases in these markets for GSK. This leader must manage difficult prioritization discussions and negotiates across stakeholders, including partnership with medical and commercial across these countries. In parallel, this leader will forge key relationships with sites and institutions across multiple countries. This leader will represent GSK R&D within the local environment, different countries and at the global level.

  GSK has an R&D Hub in Warsaw and there is an expectation that this leader will help support the Hub, which is cross functional across all of GCO (Global Clinical Operations) and R&D working to define strategy including engaging and motivating the broader organization. The role reports directly into the VP, Global Head of Monitoring and Site engagement and will work together with colleagues to set strategy for the global organization and drive global delivery for all trials (Vaccine and Pharma), sitting on the global leadership team.

  Due to the local reach of this role, it will ideally be based in Warsaw, Poland. Flexible working is available, travel (up to 30%) may be required.

  Key responsibilities:

  • Accountable for strong leadership, people management, talent retention and development within the Clinical Operations Team in country and beyond, providing direction and vision. This includes mentorship beyond current countries.

  • Translates the organization vision, mission and strategy into coherent objectives and requirements that can be understood and implemented by the team. This includes ensuring that all teams understand and operate according to the agreed business priorities, regulatory requirements and internal processes in order to ensure excellence in the delivery of studies and projects.

  • Accountable for execution and delivery of Pharma and Vaccine clinical research across all therapy areas and development phases in their country to quality, time, budget and resources as defined in the study protocol as well as in local regulations, ICH GCP / IND guidelines, and GSK written standards. He/she also has responsibility to provide clinical monitoring oversight towards studies executed by our strategic partners in the country. This oversight includes Poland and all CEE countries.

  • Responsible, with the Global Head of Monitoring and Site Engagement, and colleagues to set the tone for the global organization and participate in global work specifically relevant to innovation and changing our operating model.

  • Accountable for site engagement activities and fostering those for the benefit of patients in Poland and all CEE countries.

  • Leader withing the Polish cross R&D Hub supporting all of GCO and other R&D functions to create a unified workforce with common values and living to the GSK culture.

  • Expert knowledge of the opportunities and challenges of delivering studies within Poland and all CEE countries and ability to maintain strong collaboration and engagement with various external stakeholders as well as internal stakeholders in Research and Development (R&D) including Therapy Area Heads, Clinical and Medical Leaders, Asset Leaders, Regional Clinical Operations Directors and other Clinical Operations Managers in order to effectively deliver the portfolio and execute the R&D strategy.

  • Works with the functional heads to resolve key operational issues at local, regional and global level.

  • Actively engages with local industry partners and regulatory stakeholders to maintain and influence a positive operational environment for clinical trials in the country.

  • He/she drives, business efficiencies, implementation of new processes and quality improvement, facilitates sharing of best practices, learnings and expertise at a local, regional or global level where appropriate. This role contributes to the LOC’s immediate and long-term successes. He/she is member of the regional and global in-country clinical operations network and has above country accountabilities to ensure R&D objectives are met.

  • Ensures the quality and integrity of clinical studies conducted in the LOC by implementing quality and risk management plans. Actively identifies and manages any internal and external risks to the business.

  • Has oversight of Business Continuity Plans (BCPs).

  • Full operational and financial accountability for the clinical operations country budget(s).

  • Promotes the profile and credibility of the department with internal groups with global clinical operations and beyond as well as external groups (hospitals, GP networks, physicians, HCPs, industry initiative groups etc) in order as well to develops operational strategies (12-18m months horizon) of an adequate network of clinical sites and other external partners (ethics committees, study support vendors, etc) to support local and global development needs in support of large portfolios.

  • Ensures strategic local input is provided at early stages of clinical development planning to optimize study feasibility in-country, interacts with country medical director/Local Medical Leads and global project teams to contribute to the development of operationally robust clinical plans.

  • Develops and implements a resourcing strategy (internal staff and/or external resources) to ensure availability and competency of resources needed to meet portfolio requirements and accountable for forecasting and management of country budget(s).

  • Leads global projects and initiatives.

  • Ensures that key country feedback from investigators across multiple countries is captured and shared with relevant internal stakeholders within clinical operations and R&D to inform the design and execution of the clinical portfolio.

  Closing Date for Applications – [12th January 2024] (COB)

  Please take a copy of the Job Description, as this will not be available post closure of the advert.
  When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

  
  During the course of your application, you will be requested to complete voluntary information which will be used in monitoring the effectiveness of our equality and diversity policies. Your information will be treated as confidential and will not be used in any part of the selection process. If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements, please contact 0808 234 4391. This will help us to understand any modifications we may need to make to support you throughout our selection process.

  Why you?

  Basic Qualifications

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

  • You have successfully completed master’s degree in life sciences or related fields.

  • Extensive years of experience in pharmaceutical industry with focus on Clinical Operations.

  • Proven track record of managing people and complex programs.

  • Expert knowledge of the opportunities and challenges of delivering studies within country and ability to maintain strong collaboration and engagement with various external stakeholders as well as internal stakeholders in Research and Development (R&D) including Therapy Area Heads, Clinical and Medical Leaders, Asset Leaders, Regional Clinical Operations Directors and other Clinical Operations Managers in order to effectively deliver the portfolio and execute the R&D strategy.

  • Good combination of strategic and operational skills; ability to make flexible, but thorough decisions in a highly dynamic environment.

  • Demonstrable negotiation skills required to negotiate with auditors, both internal and external.

  • Experience in managing the navigation of decisions and/or their execution through multiple parties in complex, matrix organizations.

  • Strong written and oral communication skills in English.

  Preferred Qualifications

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

  • PhD or MD with substantial industry experience in Pharma/ Biotech R&D.

  • Be a member of the regional and global in-country clinical operations network and has above country accountabilities to ensure R&D objectives are met.

  • A strong sense of initiative, urgency, pragmatism, judgment – an ability to make things happen.

  • Provide insight into related cross-functional R&D/Research projects.

  • Proven Influencer will establish and enhance relationships with key senior management in supported customer groups.

  • Critical thinking and leadership skills will allow to Guide teams on drawing out and prioritizing strategic questions and choices.

  • Budget and vendor management.

  • Cultural sensitivity.

  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.

  If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

  GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.

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• About the company

  GlaxoSmithKline plc is a British multinational pharmaceutical company headquartered in Brentford, England.

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