Pk And Soluble Biomarker Bioanalytical External Study Monitor

Job description Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage Posted Date: Oct 30 2024 We're currently looking to expand our Bioanalysis and Biomarkers Platforms (BBP) department within Precision Medicine and seeking a Principal Scientist to join with strong exposure to PK and Biomarker Immunoassay end points.
As the successful candidate, you'll join GSK in a high visibility role where you'll be at the forefront of medicine while managing the full life cycle of GSKs studies.
Your skills as a bioanalytical scientist with drug development and regulatory understanding will help you working with internal and external partners to deliver bioanalytical endpoints for clinical studies across the GSK portfolio.
You will serve as the subject matter expert (SME) on Pharmacokinetics (PK) and Biomarkers data deliverables using various immunoassay platforms (e.g., ELISA, Gyros, MSD, Quanterix), and work closely with internal biomarker leads to define the necessary Context of Use for the data and ensure supporting analytical methods are fit for purpose.
As a bioanalytical external study monitor (BESM), you will manage the bioanalytical support externalized to CRO partners covering method development, assay transfer / validation (including cross validation), and work closely with internal team members to define timeline, outsourcing strategy, develop new processes for outsourcing to better optimize the outsourcing workflow.
You will monitor assay performance at CRO and ensure high quality PK and/or soluble biomarker are delivered to pre-agreed projects timelines and quality standard.
You will contribute to bioanalytical sections in the regulatory submission packages worldwide.
You will make recommendation on the CRO selections based on KPIs.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Contribute to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.
Provide bioanalytical life-cycle support for all phases of clinical trials, especially late phase assets.
Lead bioanalytical projects in line with agreed departmental/project timelines.
Act as the SME for biopharmaceutical PK and soluble biomarker immunoassays, internal and external; provide technical supervision in solving issues related to PK and soluble biomarker assays in clinical development.
Acts as the primary interface for communication between GSK and CRO staff Work closely with CRO partners to ensure timelines for method transfer, validation and sample analysis are met and communicate any delays.
In partnership with GSK External QA, evaluate third-party compliance with GLP, GCP Clin.
Lab, and worldwide regulations, relevant SOPs, protocols, policies and procedures.
Work closely with internal GSK stakeholders to fulfill the requested timeline and data/report delivery.
Review and contribute to clinical study report and assist the regulatory filing.
Interact with Bioanalysis and Biomarker Platforms internal group and manage reference standard and internal standard distribution from Bioanalysis and Biomarker Platforms to CROs and ensure CRO possess unexpired standards for the conduct of the study.
Represent the department in internal project teams and regulatory interactions (questions, and filings) related to PK and soluble biomarker assays.
Why you?
Basic Qualifications: ? We are looking for professionals with these required skills to achieve our goals: PhD in Biology, Biochemistry or related discipline, with 2 years pharmaceutical industry bioanalysis experience or BS in Biology, Biochemistry, or MS in Biology, Biochemistry or related discipline, with 3 years pharmaceutical industry bioanalysis experience or BS in Biology, Biochemistry, or related discipline with 5 or more years of pharmaceutical industry bioanalysis experience.
Must have experience with method development, method validation, trouble-shooting etc.
on various modalities.
Analysis preparation and reporting of clinical biopharmaceutical PK, biomarker data and its context to the study/project.
Must have worked under GLP, GCLP bioanalysis principals.
Department Representative at project teams and regulatory interactions.
Data interpretation experience both bioanalytically and secondary outputs such as PK/PD.
Preferred Qualifications: If you have the following characteristics, it would be a plus: Previous study monitoring experience are preferred.
Experience in mentoring young scientists in a regulated bioanalysis environment.
Peer recognition in pharmaceutical industry by publication at peer review journals and podium/poster presentations at international conferences.
Experiences of contributing to bioanalytical sections in the regulatory submission packages worldwide, especially in the emerging markets.
Experience in study set up and management of regulated studies in Thermo Watson LIMS.
Experience in tools or software for tracking CRO key performance index and study/schedule plan.
Experience of working through contract negotiations with partners and 3rd parties.
Excellent communication skills – will need to interface between many functional areas including external suppliers, internal study teams, SMEs and QA.
Excellent attention to detail – reviewing validation plans, study plans, validation and bioanalytical reports, and assisting with reconciliation of study samples.
Cultural sensitivity.
Willingness to travel if needed.
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: Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
Continuously looking for opportunities to learn, build skills and share learning.
Sustaining energy and well-being Building strong relationships and collaboration, honest and open conversations.
Budgeting and cost-consciousness Please visit  GSK US Benefits Summary t o 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.
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 Employer and, in the US, we adhere to Affirmative Action principles.
This ensures that 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.