NHS Human Services, Inc.

Mobile nhs-human-services Logo

Job Information

GlaxoSmithKline LLC Supply Chain Study Lead in Collegeville, Pennsylvania

Reference #: 394805 Site Name: UK - Hertfordshire - Ware RD, Belgium-Rixensart, USA - North Carolina - Zebulon, USA - Pennsylvania - Upper Providence Posted Date: Jun 19 2024

The Supply Chain Study Lead (SCSL) role provides tactical oversight of the end-to-end supply chain for assigned GSK R&D clinical studies.  The SCSL is accountable for defining detailed demand and supply plans for investigational medicines that consistently deliver those medicines on-time to patients while ensuring the supply chain delivers results that support published study milestones.

This role is responsible for reviewing and influencing clinical protocols relative to investigational product (IP) supply and determining optimal supply plans that are patient-focused, risk-adjusted, and cost effective.  Furthermore, the SCSL ensures timely execution of the plans and follows through on supply chain performance to ensure the successful delivery of the supply chain.

This role supports Phase I through IV GSK sponsored clinical studies as well as investigator sponsored trials and compassionate use studies.

In this role you will Accountable for the delivery of Investigational Product supply at a study level, through robust supply plans and distribution strategy. Creates demand plans based on varied study-specific inputs (e.g. patient enrolment forecast, treatment regimen, treatment duration etc.). Ensures full visibility of requirements in relevant planning systems and accountable for meeting monthly Demand and Operations Planning requirements. Proactively builds engagement and challenges Clinical study teams to ensure supply options and risks are explored and agreed in alignment with over-arching study objectives. Engages with and influences cross-functional teams to coordinate and manage the delivery of clinical supplies for assigned studies. Accountable for complex problem solving, risk mitigation and resolution of issues involving a range of technical, quality, regulatory and operational issues to ensure patient supply. Accountable for ensuring that label content is defined and liaising with relevant groups on pack design and pack component suitability. Accountable for ensuring appropriate RTMS contract and setup parameters are in place and are coordinated with supply plans and distribution strategy.

Why you? Qualifications & Skills: We are looking for professionals with these required skills to achieve our goals: B.S., M.S., Pharmacy, Chemistry or Logistics or equivalent experience in relevant field.

Preferred Qualifications & Skills: If you have the following characteristics, it would be a plus: APICS or CILT certification Lean Sigma training / experience Project Management training / experience Experience working with clinical trial study designs and approaches and their implications for supply chain Experience demonstrating knowledge in the management of investigational product supplies and experience in inventory management Demonstrated working knowledge of supply chain and planning principles Ability to manage multiple and complex projects that require strong problem solving skills and creative or innovative thought to address global supply problems Knowledgeable in regulatory requirements including Good Manufacturing Practices (GMPs) and Good Clinical Practices (GCPs) and the Trial Master File Demonstrated understanding of the drug development process Knowledgeable and experienced in working with Interactive Response Technology (IRT) systems, especially with respect to supply management and patient randomization. Experience demonstrating organizational and planning skills coupled with strong written and oral communication skills Demonstrated capability to work with aggressive and changing timelines and with limited information and without defined absolutes. Knowledge of the technical challenges with regards to investigational product packaging and labeling.

Closing Date for Applications: Wednesday 3rd July 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.

#LI-GSK

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.

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).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting t

DirectEmployers