Manager, Bioanalysis Immunogenicity and Biomarkers (BIB) Planning and Performance Specialist
Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2021 Are you energized by networking with key opinion leaders and leveraging your broad scientific expertise to accelerate the development of medicines? If so, this Manager, Bioanalysis Immunogenicity and Biomarkers (BIB) Planning and Performance Specialist role could be an exciting opportunity to explore. We have a great opportunity for you in the Bioanalysis, Immunogenicity and Biomarkers (BIB) department at GSK! We are looking for a Lead Planning and Performance Specialist with knowledge and experience in drug development, bioanalytical and project management based in Upper Providence, PA, US, or Stevenage, UK. As a Lead BIB Planning and Performance Specialist, you will direct the resource, budgetary activities and business performance tracking across BIB (e.g., scientific groups in UK & US, various analytical platforms, reagent generation, automation, etc.). This includes all BIB deliverables in toxicology and clinical studies, , internal and external work and the interface with 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 Project Specialists, Clinical Operations, and Project Managers). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… This role will provide you the opportunity to lead key activities to progress your career. These responsibilities include some of the following: Appointed at Candidate Selection to lead the planning activities across various scientific lab groups in BIB to include all BIB deliverables in both toxicology and clinical studies, internally & externally supported. Act as a central BIB contact for study/project team on all planning activities (e.g., timelines, budgeting). Responsible for coordination of the bioanalytical portion of preclinical and clinical study support conducted in house or at contract research organizations (CROs), focusing on BIB deliverables, resource and budgetary requirements. Using your project management skills, you will oversee the coordination of assay requirements, reagent development, resource placement, performance tracking. Use expertise to refine/develop new ways of working to maximize the capacity of the team and deliver training for identified process improvements. Track and lead the improvement on the communication and interface between BIB and development teams regarding BIB deliverables: study milestones/timelines, sample shipment schedules and bioanalytical data requirement milestones. Work with GSK Project Managers to deliver an accurate project plan for BIB, provide budget forecasting and keep the project plan live throughout the study. Provide BIB Leadership Team regular reports on capacity and demand analysis across lines/platforms Track progress, business performance, issues and resolutions on all BIB deliverables to study/project teams, in & out Own BIB outsourcing strategy and interface with Procurement to deliver CRO selection and provide invoice approvals Act as the lead to the implementation of cross line new business solutions May include line management responsibility for 1-3 staff Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Biological/Chemical/Pharmaceutical Sciences, Business or Project Management. Seven or more years of pharmaceutical industry or related experience. ' Preferred Qualifications: If you have the following characteristics, it would be a plus: MS Degree in Biological/Chemical/Pharmaceutical Sciences, Business or Project Management. Ten or ore years of pharmaceutical industry or related experience. Project management experience, Master of Business Administration (MBA) or Project Management Professional (PMP) certification preferred Strong business acumen, and experience in driving business performance and working with leaders to define business strategies and deliverables. Knowledge of drug development process as it applies to technical, logistical and regulatory requirements for PK 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. Capability to manage complex projects, coordinate demands and timelines, influence stakeholders and manage expectations. Excellent interpersonal, communication, presentation, and negotiation skills with internal and external partners. Familiarity with PK Bioanalysis, Biomarker, Immunogenicity and/or cellular assay delivery requirements and technical limitations. Experience working in the regulated bioanalytical space with an understanding of regulatory guidelines from health authorities such as the US FDA and EMA. Managerial experience including staff development, performance management etc. 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: 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. *This is a job description to aide in the job posting, but does not include all job evaluation details. *LI-GSK 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. 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