GSK At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. Are you passionate about regulatory strategy and oncology? Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated Global Regulatory Affairs Director who will be instrumental in developing and executing global and...

GSK Director, Global Regulatory Affairs - RNA vaccines Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Director, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore. This role will focus on the development of mRNA based vaccines within GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg. BLA, sBLA, Q&A, scientific consultations, PSP, INDs, etc.) and ensure that these documents meet high scientific...

Site Name: Durham Blackwell Street, Cambridge Park Drive, Rockville Vaccines, Upper Providence Posted Date: Nov 22 2024 Director, Global Regulatory Affairs - RNA vaccines Are you interested in a highly-visible Global regulatory affairs role that allows you to drive strategy and shape integrated regulatory development across portfolios? If so, this Director, Global Regulatory Affairs (RNA Vaccines) could be an ideal opportunity to explore. This role will focus on the development of mRNA based vaccines within GSK. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following... Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for new vaccines as rapidly as possible, with the best possible label, and to maintain these authorisations. Determine from a strategic and scientific perspective the content of regulatory documents submitted to FDA (eg....

CSL CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Associate Director, Global Regulatory Affairs? The job is located in our King of Prussia PA office. This is a hybrid...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 19 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Are you passionate about regulatory strategy and oncology? Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated Global Regulatory Affairs...

Site Name: USA - Pennsylvania - Upper Providence Posted Date: Nov 18 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Are you passionate about regulatory strategy and oncology? Within the Oncology space, we are in a period of very dynamic growth, as we continue to expand and develop our pipeline and portfolio. We are looking for a driven and motivated Global Regulatory Affairs...

Site Name: USA - Maryland - Rockville, Durham Blackwell Street, Upper Providence, USA - District of Columbia - Washington Dc, USA - Maryland - Baltimore, Waltham Posted Date: Oct 29 2024 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together. Job Purpose: Ensure the development and execution of the appropriate Regulatory strategy(ies) for assigned asset(s), across all stages of the product...

Site Name: USA - Pennsylvania - Upper Providence, UK - Hertfordshire - Stevenage, UK - London - New Oxford Street, USA - Massachusetts - Waltham, USA - North Carolina - Durham Posted Date: Dec 9 2024 Are you energized by the opportunity to partner with key leaders in global medical science to accelerate business performance across and drive global operational support? If so, this Clinical Development Director opportunity could be an ideal opportunity to explore. I. Role Purpose The Clinical Sciences Lead (CSL) is the single point accountability for the development of the scientific design, medical governance (if a physician) and interpretation of results of a study. The study designed is expected to fulfill a strategic objective of the clinical development or integrated evidence plan. II. Key Accountabilities Single point of accountability for the following: Study Design Study design, including integrated input from internal/external experts, thought leaders and...

Site Name: UK - Hertfordshire - Stevenage, GSK HQ, Upper Providence, USA - Massachusetts - Waltham, Warsaw Rzymowskiego 53, Zug House Posted Date: Dec 4 2024 Are you interested in a leadership opportunity to drive the implementation of effective Clinical Oncology strategies for a multi-national pharmaceutical company? If so, this role may be for you! As Clinical Development (Oncology) Director, you will be responsible for leading GSK medium and long-term oncology development strategies for GSK’s oncology pipeline. You will work closely with the Global Oncology Research and Development and Medical Affairs to ensure that the oncology clinical team have the highest quality capabilities and expertise. You will also ensure the optimal launch of new products and appropriate optimal patient use of currently available GSK Medicines through leadership and collaboration. Responsibilities: • Provide scientific input during protocol development, oversight of study conduct, and...

GSK At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We're uniting science, technology and talent to get ahead of disease together. As an Associate Director of Global Regulatory Affairs, you will ensure the development and execution of global and/or regional regulatory strategies for assigned assets. These strategies will be in alignment with the Medicines Development Strategy/Integrated Asset Plan, ensuring compliance with internal GSK processes and policy as well...

Site Name: UK - Hertfordshire - Stevenage, USA - Pennsylvania - Upper Providence Posted Date: Nov 27 2024 Reporting to Executive Director of Translational Respiratory Immunology Translational Unit (RITU), the Director, Translational Lead will be responsible for innovative disease area translational initiatives to inform therapy area and programme biomarker strategies to 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, 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. As a leader in RITU you will...

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...

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: USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Nov 27 2024 The will lead a team of analytical scientists responsible for development, manufacturing, release and stability testing, and characterization of drug substances, drug products and process intermediates of biologic therapeutic modalities within the Strategic External Development (SED) organization. The Associate Director will be responsible for people and project management, who would also function as an analytical project lead and technical lead in a broad analytical development role that spans from managing collaboration with appointed CDMOs to overseeing, developing, and executing aligned GSK and CDMO goals for development of biologics. It will further extend to investigation, preparation and reviewing of CMC content for regulatory submissions, as well as response to regulatory agencies. This role will provide YOU the opportunity to lead team and key activities to...

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, 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: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Nov 22 2024 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Key Responsibilities Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon,...

Site Name: USA - Pennsylvania - Upper Providence, Cambridge Park Drive, Collegeville TSA, USA - Maryland - Rockville Posted Date: Nov 22 2024 Job Purpose Ensure the development of appropriate regional regulatory strategy(s) and their execution for assigned asset(s) consistent with Medicines Development Strategy. This goal has to be achieved both as a component of an overall global regulatory approach and ensure compliance with both internal GSK process / policy and with regional regulatory requirements to deliver the best possible labeling, commensurate with the available data. Key Responsibilities Accountable to GRL and Global Regulatory TA Head for development of appropriate regional and/or global regulatory strategy(ies) and for delivery according to plans. The Regulatory Director may be the single point of contact on assigned asset(s), responsible for regional and global regulatory strategy(ies). In conducting role, planning will be on a multiple year horizon,...

Site Name: UK - London - New Oxford Street, Stevenage, Switzerland - Zug, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw Posted Date: Nov 21 2024 MEDICAL DIRECTOR- ONCOLOGY CLINICAL DEVELOPMENT Are you looking to join an ambitious oncology clinical development organisation, focusing on the development of ADCs in the GI Oncology space? If so, this role is worth reviewing. 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 effective relationships with Key External Experts. This...

Site Name: USA - Pennsylvania - Upper Providence, Belgium-Wavre, Cambridge MA, UK - London - New Oxford Street, USA - Maryland - Rockville Posted Date: Nov 21 2024 Established as a focused global function , Data Generation & Scientific Communications , is uniquely placed to help accelerate the successful integration of our medicines and vaccines into the healthcare pathway - we’re the ‘engine’ that brings our medical affairs strategies to life. Within this organization as the VP, Head of Global Real-World Evidence & Health Outcomes Research, Sulabha Ramachandran will be leading a team which incorporates the legacy VEO/Non-Interventional Studies capabilities teams under a newly evolved name that more closely reflects their purpose and the research they deliver. For drugs to be successful, there must be robust health outcomes data to support launch optimization, reimbursement and maintain market position. Specifically, evidence must be maintained throughout the...