GSK

Bioanalysis Immunogenicity and Biomarkers (BIB) Clinical Study Lead (CSL)

Employer
GSK
Location
Collegeville, Pennsylvania
Salary
Competitive
Posted
February 08 2021
Ref
278979
Organization Type
Pharma
We have a great opportunity for you in the Bioanalysis, Immunogenicity and Biomarkers (BIB) department at GSK! We are looking for a passionate scientist with proven knowledge and experience in drug development, bioanalytical and project management to serve as BIB Clinical Study Lead (CSL) based in Upper Providence, PA, US, or Stevenage/Ware UK.

As a BIB CSL, you will represent BIB on cross-functional drug development teams, and act as the bioanalytical liaison and point of contact for internal partners (e.g., BIB extended leadership team, technical experts, Bioanalytical External Study Monitors) and external collaborators (e.g., Clinical Pharmacology Modeling and Simulations, Clinical Biomarker Leads, DMPK Disposition Reps, Clinical Operations, and Project Managers).

Key Responsibilities:
  • Align bioanalytical strategies for drug development programs among group leaders and subject matter experts (SMEs) within BIB.
  • Coordinate the bioanalytical portion of clinical study support conducted in house or at contract research organizations (CROs), focusing on BIB deliverables and timelines. This may include coordination of assay requirements, reagent development, resource placement, performance tracking, issue escalation.
  • Communicate between BIB and development teams regarding BIB deliverables, study milestones/timelines including sample shipment schedules and bioanalytical data required by date, and emerging BIB issues (timeline, quality, etc.).
  • Assist in and coordinate the preparation of regulatory documents, including INDs, NDAs, MAA, and BLA submission documents, and responses to regulatory agencies related to BIB in collaboration with SMEs.
  • Collaborate with Bioanalytical External Study Monitors (BESMs) and contract managers for timely coordination of CRO support for drug development programs.
  • Provide budget forecasting for BIB Clinical Validations and Clinical Sample Analysis to Project Managers and providing updates throughout the study.
  • Keep the project plan up to date for BIB clinical work packages.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelor's or master's degree in Biological Sciences with >10 years of pharmaceutical industry experience, or PhD with greater than 5 years of relevant experience.
  • Experience with the drug development process, especially of biotherapeutics and oncology indications, as it applies to technical, logistical and regulatory requirements for bioanalytical, immunogenicity and biomarker assays.
  • Experience working on cross-functional drug development teams, representing the bioanalytical function and driving/delivering bioanalytical strategies and commitments to study teams in a matrix environment.
  • Experience with LC/MS, LBA, or cell-based assays as applied to bioanalytical deliverables supporting PK Bioanalysis, Biomarker and Immunogenicity analyses.
  • Experience working in GCP or GLP environments
  • Experience preparing regulatory documents related to bioanalysis, immunogenicity and biomarkers.


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Experience providing analytical support for cell and gene therapy modalities is a plus.
  • Capability to manage complex projects, coordinate demands and timelines, influence stakeholders, manage expectations and align project strategies among stakeholders.
  • Excellent interpersonal, communication, and negotiation skills with internal and external partners.
  • Project management experience


Why GSK?

Our values and expectationsare 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:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk.
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.


*LI-GSK

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