146 science jobs found in Collegeville, PA

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 27 2024 Reporting to Director of Translational in Respiratory Immunology Translational Unit (RITU), the Associate Director Translational Leader will be responsible for project translational strategies within the wider context of innovative disease focused initiatives to inform that will increase the probability of success of preclinical to clinical transitions and allow for earlier and higher confidence project-related decision makings. This will include generation of foundational data as well as disease biomarkers development and validation that allow timely deployment of tools/biomarkers that can support detection of Proof of Mechanism (PoM), signs of clinical efficacy, and Proof of Concept (PoC), and pairing MoAs with patient subtypes to predict rapid or complete responder populations in respiratory, immunology, or emerging specialities. As a leader in RITU you will work closely across translational &...

Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Nov 27 2024 Reporting to Vice President of Respiratory and Immunology Translational Unit (RITU), the Executive Director, Translational Sciences will be responsible for innovative disease area translational initiatives to inform therapy area and programme biomarker strategies that will increase the probability of success of preclinical to clinical transitions and allow for earlier and higher confidence project-related decisions. This will include generation of foundational data as well as disease biomarkers development and validation that allow timely deployment of tools/biomarkers that can support detection of Proof of Mechanism (PoM), signs of clinical efficacy, Proof of Concept (PoC), and pairing Mechanisms of Action (MoAs) with patient subtypes to predict rapid or complete responder populations in respiratory, immunology, or emerging specialities. The successful candidate will...

GSK Are you looking for a highly visible regulatory leadership role where you can build advocacy and accelerate regulatory compliance on an international scale? If so, this role could be an exciting opportunity to explore. As an Associate Director of Global Regulatory Affairs , you will be responsible for leading regulatory strategy for mRNA Vaccines assets, securing product licensure in key markets identified in the Integrated Asset Plan (IAP) and securing best possible labeling for our Vaccine products. The Associate Director will be accountable to the Asset GRL (Global Regulatory Lead) for development of appropriate US regulatory strategies and for delivery according to plans. Planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK, and representing GSK with the FDA and possibly other agencies. This role will work within the larger GSK matrix organization (ie. Vaccine development Team, Commercial etc.) to ensure a...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Dec 31 2024 Key Responsibilities: We are seeking a highly motivated and talented Principal Scientist to join our Infectious Disease Research team with expertise in immunology and virology in Upper Providence, Pennsylvania. The Infectious Disease team is part of the Research Team within Vaccines/ID Research, which is one of the three therapeutic aligned research teams here at GSK. This position supports designing, executing, and analysing experiments to support drug discovery projects through to pre-clinical evaluation. The successful candidate will be responsible for running and leading preclinical in vitro/ in vivo studies aimed at exploring the HBV-specific immune and anti-viral responses, delivering a preclinical data package for validating immunomodulator(s) and/or antivirals for cure of chronic hepatitis B infection, and validating immunological and viral biomarkers to predict a functional cure. The...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Apr 2 2024 Are you an ambitious Oncology Clinical Development professional looking to advance your career in the pharmaceutical industry? Take a look at this position and engage with us to explore broader opportunities in GSK's Oncology Clinical Development division today. The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities. This individual will also have a leading role in managing effective relationships with Key External Experts. This role requires a physician capable of developing and executing...

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Canada - Ontario - Mississauga, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham Posted Date: Sep 16 2024 Would you like to be part of GSK’s Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore. Job Purpose The Associate Director in Epidemiology will support epidemiological strategy for programs led by the Epidemiology Cluster Head- Bacterial vaccines. The goal is to ensure high quality and on-time delivery of epidemiology data that will allow and support world-wide registration in compliance with the epidemiology plan, applicable good practices, and non-interventional studies standard operating procedures (SOP). As an Associate Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Ware, USA - Massachusetts - Waltham Posted Date: Oct 16 2024 Are you interested in a highly-visible US regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Regulatory Affairs Management Manager could be an ideal opportunity to explore. As a Regulatory Affairs Management Manager/Associate Director, you will be responsible for regulatory submissions, interactions, and strategy related to products within the US. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Drives the CMC strategy coordinates the timely preparation and authors, as needed, technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards, and...

Site Name: USA - Pennsylvania - Upper Providence, Belgium, UK - Hertfordshire - Stevenage, UK - London, UK - London - New Oxford Street, USA - Massachusetts - Cambridge, USA - Massachusetts - Waltham, USA - North Carolina - Durham, USA - Pennsylvania - Philadelphia Posted Date: Sep 12 2024 Are you looking for a role where you will serve as a key strategic partner representing Global Regulatory activities? If so, this Director of Regulatory Affairs, CMC could be an exciting opportunity to explore. This role will provide strategic direction and guidance on both global project and key strategic business initiatives. Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and multiple modalities for...

Site Name: Upper Providence, Belgium-Wavre, Mississauga, USA - Massachusetts - Waltham Posted Date: Aug 20 2024 Would you like to be part of GSK’s Global Epidemiology, Vaccines team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore. Job Purpose The Director in Epidemiology will support epidemiological strategy for programs led by the Epidemiology Cluster Head- Bacterial vaccines. The goal is to ensure high quality and on-time delivery of epidemiology data that will allow and support world-wide registration in compliance with the epidemiology plan, applicable good practices, and non-interventional studies standard operating procedures (SOP). As a Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to answer key challenges identified across all phases of vaccine development for an asset or...

Site Name: USA - Pennsylvania - Upper Providence, GSK HQ, RTP, UK - Hertfordshire - Stevenage Posted Date: Nov 8 2024 Would you like to be part of GSK’s Epidemiology Department, with an opportunity to drive Epidemiology strategy and studies across the spectrum of drug development? If so, this is an excellent opportunity to explore. Job Purpose As a Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to answer key challenges identified across all phases of drug development for an asset or disease area to deliver new drugs more efficiently and effectively to patients. This position functions within the Epidemiology Department, which contributes to the successful development of new drugs. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the entire spectrum of drug development, from early discovery to registration and lifecycle...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Oct 31 2024 We are seeking a highly motivated, flexible, and experienced scientist with demonstrated expertise in reagent generation and characterization. This individual will support for generation and characterization of critical reagents in a timely manner for development, validation, and execution of bioanalytical, immunogenicity and biomarker assays to support clinical development. The successful candidate will work closely with bioanalytical, immunogenicity and biomarker assay groups and cross-functional teams in GSK to identify, generate, select, and qualify critical reagents, as well as their monitoring, tracking, and storage. The role is based in our R&D hub at Upper Providence US. In this role you will Participate in laboratory activities and provide scientific expertise to prepare and analyze critical protein reagents in support of the bioanalytical laboratory. Conduct day-to-day experimental...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 6 2024 The new Research Tech Data & Predictive Sciences function is focused on harnessing the power of GSK’s data-as-an-asset to drive research productivity. As a member of the Cheminformatics (CIX) group, you will be focused on developing, integrating and embedding advanced computational methods and predictive in silico models that accelerate the discovery of medicines. Data & Predictive Sciences will only be successful by working in close collaboration with Research Tech, Therapeutic Areas, GSK Tech, AIML, Vaccines, Risk & Compliance, and across lines within the function itself, and by developing and fostering a high-performing team culture of collaboration, curiosity, consistency, agility, quality, peer review, and continuous improvement with a relentless focus on enabling value realization through end-user uptake and measuring impact. We create a place where people can grow, be their...

Site Name: UK - Hertfordshire - Stevenage, Belgium-Rixensart, UK - Hertfordshire - Ware, USA - Pennsylvania - Upper Providence Posted Date: Nov 8 2024 Are you energized by a highly visible senior R&D Global Clinical Supply Chain (CSC) leadership role that will allow you to drive and shape scientific innovation across GSK's vaccine and medicine portfolio? If so, the Executive Director Clinical Interface may be an exciting opportunity to explore. The primary purpose of the Executive Director Clinical Interface is to lead the R&D Clinical Supply Management for Medicines and Vaccines. This includes delivering optimized demand/supply planning and supply chain setup, scenario planning, and input into study delivery teams across the entire R&D Portfolio, including ViiV. The role ensures the supply and oversight of clinical supply to all R&D clinical programs/studies, R&D supported studies, and R&D Managed Access Programs for Vaccines and Medicines. The...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 11 2024 Job Purpose Responsible to lead medical and scientific staff within the SERM (Safety Evaluation & Risk Management) and defining and driving the strategy and vision of clinical safety and pharmacovigilance activities in alignment with Global Safety business strategies. As a senior member of the Global Safety organization the role is responsible to: Implement policy, processes and support the implementation of operational and strategic plans Ensure scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and...

Site Name: Collegeville TSA, Durham Blackwell Street Posted Date: Nov 8 2024 Purpose of this role is to provide independent Pharmacovigilance (PV) Quality Assurance within GSK R&D by delivering comprehensive risk-based audit programs. This role will define audit scope and methodology to conduct audits and ensure the delivery of audit reports with and end-to-end process driven approach. This role involves identifying compliance issues, trends, within the scope of R&D to ensure compliance with relevant international regulatory agency regulations/guidelines, GSK policies/procedures and accepted principles and improving overall processes. Additionally, the role includes supporting QA activities during regulatory inspections, building solid working relationships with stakeholders, and maintaining knowledge of local regulatory frameworks and global regulatory reporting requirements. This role will provide YOU the opportunity to lead key activities to progress YOUR career,...

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, Mississauga, Montreal Queen Street, USA - Massachusetts - Boston Posted Date: Nov 5 2024 Associate Director Epidemiology Vaccines Would you like to be part of GSK’s Vaccine Epidemiology team, with an opportunity to drive Epidemiology strategy and studies across the spectrum of vaccine development? If so, this is an excellent opportunity to explore. Candidates with significant skills and experience may be considered for Director level as opposed to Associate Director. Job Purpose To be responsible for Epidemiological studies within a large program or group of related programs (led by a senior epidemiologist) within the context of the GSK Vaccines process in order to ensure the high quality and on-time delivery of all epi data that will allow and support world-wide registration in compliance with the clinical and epi development plan, applicable good practices, and GSK Vaccines standard...

Site Name: USA - Pennsylvania - Upper Providence, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Philadelphia Posted Date: Oct 31 2024 Accountable to GRL and Global Regulatory TA Head for development of appropriate regional regulatory strategy(s) and for delivery according to plans. In conducting role, planning will be on a multiple year horizon, with delivery requiring extensive matrix working within GSK to VP level and representing GSK with at least the local regulatory agency. Work with the Early/Medicine Development Team (EDT/MDT) or GRL, to ensure a robust regulatory strategy is in place to support the development program to meet the needs of the key markets identified in the Integrated Asset plan and the Medicine Profile. Work closely with local / regional commercial team to secure best possible labelling commensurate with the available data. Lead interactions with local / regional regulatory authorities. Key Responsibilities:...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 15 2024 Job Purpose Provides in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or the post-marketing setting. Ensures scientifically sound review and interpretation of data and management of safety issues and escalates safety issues identified through the safety review process to senior management and safety governance as appropriate. Makes recommendations for the further characterization, management, and communication of safety risks. Focus on efficiency and effectiveness to meet the needs of our Patients and HCPs. Supporting the pharmacovigilance and benefit-risk management of the assigned portfolio of GSK global assets to ensure Patient Safety globally. If appointed as a manager (i.e., Team/Group Leader) is responsible for leadership of a team of individual contributors. Line Management (including functional matrix...

Site Name: USA - Pennsylvania - Upper Providence, Mississauga Milverton Drive, UK - London - New Oxford Street Posted Date: Nov 13 2024 Would you like to be part of GSK’s Epidemiology Department, with an opportunity to drive Epidemiology strategy and studies across the spectrum of drug development? If so, this is an excellent opportunity to explore. Job Purpose As an Associate Director in Epidemiology, you will provide scientific leadership in the application of epidemiological expertise and methods to answer key challenges identified across all phases of drug development for an asset or disease area to deliver new drugs more efficiently and effectively to patients. This position functions within the Epidemiology Department, which contributes to the successful development of new therapies. Our staff in Epidemiology provide leadership and expertise to develop and execute the Epidemiology strategy across the entire spectrum of drug development, from early discovery to...

Site Name: USA - Pennsylvania - Upper Providence, Switzerland - Zug, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53 Posted Date: Nov 21 2024 Are you a pharma physician or academic clinician keen to be part of GSK's growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? .If so, this position is a must to consider. THE POSITION: The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL), Oncology Clinical Development. The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders so as to lead clinical data generation activities. This individual will also have a leading role in managing...