Job Opportunities in Poland
September 3, 2024
GSK
Poznań
Local Delivery Lead
Site Name: Warsaw, Poznan Grunwaldzka
Posted Date: Sep 3 2024
Local Delivery Lead (Pharma)
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
Why GSK?
At GSK we offer a wide range of additional benefits:
#LI-GSK
#LI-HYBRID
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.
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
Posted Date: Sep 3 2024
Local Delivery Lead (Pharma)
Provides leadership, oversight and manages the activities of within-country operational planning and delivery of Phase I-IV clinical trials in a specific country or cluster of countries; across all therapy areas (Rx and Vx) to the required quality standards, GSK written standards, local regulations and ICH GCP. In a senior capacity, will lead a portfolio of studies within-country or cluster of countries and act as a role model, coach, mentor for less experienced LDLs on processes, technical and behavioral competencies.
Job purpose and key responsibilities:
Job purpose and key responsibilities:
-
Leads the local study team consisting of within-country clinical operations team members, cross-functional experts (medical, regulatory, supply logistics, finance, legal, etc.), vendor staff and external clinical site staff involved in study preparation and delivery; providing both matrix leadership and project mangement of study activities within the countr(ies)
-
Accountable for within-countr(ies) delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs
-
Demonstrates the ability to effectively manage multiple priorities and responsibilities of increased scope and complexity
-
Ensures that critical study timelines related to study activities within-countr(ies) are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality are met. Provides trouble-shooting and problem resolution support for within-country study team to ensure productive, efficient study delivery
-
Identifies and resolves or escalates issues and risks that may impact study delivery. Takes a leadership role in identifiying the root cause of issues, implementing/influencing corrective and preventative actions locally or at a broader study level
-
Has the accountability to estimate, track and deliver against the local budget for the studies within their scope of responsibility.
-
As required, advises on contract development with Sites/CRO/Vendors and may participate in budget/contract negotiations with study vendors or clinical investigator sites
-
As required, prepares the local Informed Consent Form and coordinates the submission of the Clinical Study Application to Regulatory Authority (RA) and local Ethics Committees (ECs)
-
Maintains communication with RA and ECs to ensure all regulatory requirements are met in a timely manner throughout the study
-
Takes a leadership role in standardizing processes within and across countries, identifying and sharing best practices in support of continuous improvement. Represents local/regional clinical operations on global and cross functional initiatives. May serve in a subject matter expert (SME) capacity locally/globally
-
Continuously develops knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring, site and project management skills and capabilities. Serves as an expert in ICH GCP and GSK written standards for LDLs
-
Available and willing to travel as job requires (approx.15%)
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
-
Bachelors degree or equivalent. Any general science degree e.g. life science, medicine, clinical research, pharmacy etc.
-
Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 5 years’ experience in clinical operations is required
-
Solid operational knowledge of clinical research with experience in all stages of study lifecycle (start-up, recruitment and close out) and understanding of R&D and drug/vaccine development process
-
Effective at problem solving, negotiation and conflict resolution skills in a matrix environment
-
Stakeholder management skills required as the role includes interactions with external clinical site staff and senior stakeholders at a central or local level.
-
Strong written and verbal communications skills are required in English and local language of the countr(ies)
-
Recognizes and reacts to changes that impact a study and/or program or practices, and has the skill set to assess the appropriateness of protocol/plans in the local environment
-
Strong project management skills; comfortable projecting, managing, and reporting budget information (business and financial acumen) and able to develop scenarios and effective contingency plans
-
Knowledge or ability to acquire expertise regarding use of multiple systems / tools related to clinical studies
-
Deep knowledge of human research regulations in the countr(ies), IND/GCP/ICH-guidelines and GSK SOP/POL/guidelines
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
-
Masters of Science, Ph D or equivalent coupled with previous project management experience
Why GSK?
At GSK we offer a wide range of additional benefits:
-
Career at one of the leading global healthcare companies
-
Hybrid work ( 2 days per week from the office)
-
Contract of employment
-
Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
-
Life insurance and pension plan
-
Private medical package with additional preventive healthcare services for employees and their eligible
-
Sports cards (Multisport)
-
Possibilities of development within the role and company’s structure
-
Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, Linked In Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)
-
Extensive support of work life balance (flexible working solutions, short Fridays option, health & well-being activities).
-
Supportive community and integration events
-
Modern office with creative rooms, fresh fruits every day
#LI-GSK
#LI-HYBRID
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.
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.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
We regret to inform you that this job opportunity is no longer available
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