Bioanalysis Immunogenicity and Biomarkers (BIB) Planning and Performance Specialist

Jun 10, 2021
Sep 17, 2021
Jobseeker Type
Organization Type
Site Name: China - Shanghai - PuDong New District - Lane 999 Huanke Road - Building18, UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Jun 10 2021 Are you looking for a role that can build upon your business operational and planning experience in a scientific environment? Are you bilingual in Manadarin and English? If so, this Bioanalysis Immunogenicity and Biomarkers (BIB) Planning and Performance Specialist role may be an ideal opportunity to explore! We have a great opportunity for you in the Bioanalysis, Immunogenicity and Biomarkers (BIB) department at GSK! We are looking for an Operations and Business Performance specialist with knowledge and experience in drug development, bioanalytical and project management to primarily support our China-based studies . The successful candidate can be located in Shanghai, China, Upper Providence, PA, US, or Stevenage, UK. As a BIB China Business Lead, you will support the resource and budgetary planning activities and business performance tracking across BIB (e.g., China-based CROs, various analytical platforms, reagent generation, automation, etc.). This includes all BIB deliverables inclinical studies, 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 Lead the planning activities across various scientific lab groups in BIB to include all BIB deliverables in clinical studies in China Act as a central BIB contact for China 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 for China-based studies. 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. Support provision of data for BIB Leadership Team on capacity and demand analysis Track progress, business performance, issues and resolutions on all BIB deliverables to study/project teams, in & out Interface with Procurement to deliver CRO selection and provide invoice approvals Why You? Basic Qualifications: Bachelor's or master's degree in Biological/Chemical/Pharmaceutical Sciences, Business or Project Management Five or more years of pharmaceutical industry or related experience. Fluent in written and spoken English and Mandarin Preferred Qualifications: Experience in working with leaders to define project/study strategies and deliverables. Knowledge of 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 of coordinating multiple demands and timelines, stakeholder influence and managing expectations. Excellent interpersonal and communication, skills with internal and external partners. Experience in working with China local operating companies and CROs preferred. 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 NMPA. 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 stake older relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *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. 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. 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