GSK We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Global Clinical Development Associate Director GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for Clinical Operations Leaders who have experience leading global oncology studies. The Role Reporting to the Study Delivery Lead (Team) Director, this job...

GSK We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Global Clinical Development Associate Director GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us grow our internal expertise! We have an exciting (and expanding) portfolio and are looking for Clinical Operations Leaders who have experience leading global oncology studies. The Role Reporting to the Study Delivery Lead (Team) Director, this job...

Site Name: UK - London - New Oxford Street, Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw Posted Date: Sep 23 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Global Clinical Development Associate Director GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us grow our internal expertise! We have an exciting...

Site Name: UK - London - New Oxford Street, Belgium-Wavre, Canada - Ontario - Mississauga, UK - Hertfordshire - Stevenage, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence, Warsaw Posted Date: Sep 23 2024 We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme. We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK Global Clinical Development Associate Director GSK continues to expand its oncology organization, and we are looking for experienced professionals to help us grow our internal expertise! We have an exciting...

Boehringer Ingelheim Description The Director has responsibility for pharmacovigilance risk management activities of marketed and/or investigational compounds on global level. This may include a portfolio of products/investigation compounds within an assigned disease area or TA. In addition to reporting to US line management, this position may matrix report into a Head Risk Management TA X, Global Pharmacovigilance. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and...

Merck Job Description Our company has an exciting and growing Pulmonary Arterial Hypertension (PAH) and Rare Disease pipeline, reinforcing our position as a sustainable innovation engine for the coming decade. Our Global Market Access (GMAx) organization is dedicated to delivering breakthrough innovations that extend and improve the lives of individuals worldwide. Our focus is on innovation and launch execution excellence, translating scientific advancements into impactful medicines that help people globally. Reporting to the Associate Vice President, Global Market Access, Global Pharma, the Executive Director, Global Market Access, PAH and Rare Disease will be a member of the GMAx Pharma leadership team and will lead a team across the PAH/RD portfolio. The Executive Director, Global Market Access, PAH and Rare Disease will play a leadership role in developing an integrated global market access, pricing and reimbursement strategy for our exciting Pulmonary Arterial...

Merck Job Description Our company has an exciting and growing Pulmonary Arterial Hypertension (PAH) and Rare Disease pipeline, reinforcing our position as a sustainable innovation engine for the coming decade. Our Global Market Access (GMAx) organization is dedicated to delivering breakthrough innovations that extend and improve the lives of individuals worldwide. Our focus is on innovation and launch execution excellence, translating scientific advancements into impactful medicines that help people globally. Reporting to the Associate Vice President, Global Market Access, Global Pharma, the Executive Director, Global Market Access, PAH and Rare Disease will be a member of the GMAx Pharma leadership team and will lead a team across the PAH/RD portfolio. The Executive Director, Global Market Access, PAH and Rare Disease will play a leadership role in developing an integrated global market access, pricing and reimbursement strategy for our exciting Pulmonary Arterial...

Merck Job Description The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company. Position Description/Summary: The GPAM Associate Director, Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering with team leaders to develop strategies and execute our Company's drug and vaccine development efforts to progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and mastery of project management to take on challenging assignments with minimal guidance. Projects could span any therapeutic areas in which our company is actively engaged. In addition to project work, the Associate Director is expected to contribute to ongoing business process improvement and talent...

Merck Job Description The drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division organization of our company. Position Description/Summary: The GPAM Associate Director, Project Manager, is a core member of Early Drug Development and/or Late Drug Development Teams, partnering with team leaders to develop strategies and execute our Company's drug and vaccine development efforts to progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient influence and mastery of project management to take on challenging assignments with minimal guidance. Projects could span any therapeutic areas in which our company is actively engaged. In addition to project work, the Associate Director is expected to contribute to ongoing business process improvement and talent...

AstraZeneca This role is responsible for ensuring implementation of the operational site relationship management strategy for US SMM at AstraZeneca. The individual will work collaboratively with business stakeholders to position AstraZeneca as the Sponsor of Choice for clinical sites. This role will require influential leadership skills and effective collaboration and partnership with sites, clinical, legal, contracts, global feasibility, CRO partners and other functions within AstraZeneca to develop and manage a best-in-class site relationship model. This role will also support site feasibility. Main Duties & Responsibilities Establish strategic partnership models and framework to be deployed across key clinical sites. Strengthen relationship between sites and AZ clinical teams to enhance performance and overcome roadblocks in site feasibility, site start-up and execution and thereby becoming a partner of choice for the sites. Support Operational feasibility...

Novartis Job Description Summary This is a Remote Based position and will be covering our Northeast Region. Candidates must be located near an airport hub- Northeast locations highly desirable. The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. The Senior CRA is responsible to deliver data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. Job Description Your Key Responsibilities: Trial Monitoring strategy: * Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of trials: * Is the frontline liaison between Novartis...

Novartis Job Description Summary This is a Remote Based position and will be covering our Southwest Region. Candidates must be located near an airport hub, Texas, Louisiana, Arizona, Arkansas, Oklahoma, Florida, - highly desirable locations. The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. The Senior CRA is responsible to deliver data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. Job Description Your Key Responsibilities: Trial Monitoring strategy: * Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of...

Novartis Job Description Summary This is a Remote Based position and will be covering our Southwest Region. Candidates must be located near an airport hub, Texas, Louisiana, Arizona, Arkansas, Oklahoma, Florida, - highly desirable locations. The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country. The Senior CRA is responsible to deliver data within timelines and required quality standard, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. Job Description Your Key Responsibilities: Trial Monitoring strategy: * Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis) Allocation, initiation and conduct of...

Merck Job Description This position will be responsible for providing engineering leadership and cross-functional project support at the Rahway, NJ FLEx (Formulation, Laboratory & Experimentation) center. Areas supported include Oral Solid Dosage (OSD) and Sterile operations, the RY119 Development Center, and Global Clinical Supply (GCS) Packaging within the scope of Our Company's Research Labs Pharmaceutical Sciences (Pharm Sci), Pharmaceutical Operations Engineering group (Pharm Ops Engineering). The FLEx facility (inclusive of RY119) supports the formulation and filling of clinical, stability, and developmental Sterile, OSD and Inhalation supplies. These facilities support critical program needs related to new products undergoing process development, new products undergoing scale-up, launch and transfer to the supply network and existing commercial products undergoing process optimization. Primary responsibility will be to maintain the Rahway based clinical...

AstraZeneca Are you passionate about science and experience within regulatory affairs and drug development ? We are now recruiting a D irector, Clinical Regulatory Writing (CReW). I n this role you will provide expert leadership to the delivery of the CVRM product pipeline through partnering with senior leaders to define and lead the global communications strategy. You will be a leader for clinical regulatory writing activities within the disease area for cross functional teams and external vendor partners. This opportunity is available at our Boston Seaport, MA (USA) location . We expect employees to be on-site for a minimum of three days per week and are therefore unable to offer remote based working. Director CReW develops communications strategies to guide these programs while advocating and developing best practices for document and accelerated submission delivery, representing strategic communications expertise in business process optimisation and improvement...

Merck Job Description The Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical research activities involving investigational compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical development, including determination of appropriate disease indications to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, the Executive Director may be responsible for: Evaluating pre-clinical and translational work for the purpose of generating the early clinical development plan and Investigational New Drug applications. Providing clinical development support of business development assessments of external opportunities to grow the Immunology Pipeline Developing clinical development strategies for investigational drugs and planning clinical...

GSK The increased demand both internally and externally for high quality, robust RWE from RWD requires GSK to access and partner with the external RWD environment to ensure evidence generation is held up to the highest possible standards. The RWD Strategy team is a small team in Biostatistics, R&D tasked with realising the potential of RWD and RWE. The vision is to build an RWD ecosystem to drive expanded use, enabling better evidence generation and decision making across R&D. The team aims to be leaders in building innovative partnerships and contributing to the future evolution of high quality RWD for research. This role, reporting to Sr Director of RWD Strategy and Partnerships, will give you the opportunity to drive forward this vision through leading efforts within the Respiratory and Immunology portfolio from Research through Development and Medical Affairs, as well as contributing to building the enterprise-wide RWD framework. The role will have the following...

Boehringer Ingelheim Description The Associate Director of Drug Metabolism and Pharmacokinetics is responsible for outsourcing, oversight and monitoring of Drug Metabolism and Pharmacokinetics (DMPK) bioanalytical work packages directly supporting clinical trials. In this role, you will represent DMPK-US as Trial Bio-analyst on clinical trials teams. Additionally, this role will represent Boehringer Ingelheim - specifically DMPK in interactions with external vendors (i.e., CROs), including oversight and business review. Other responsibilities in this role includes serving as liaison between DMPK scientists, Clinical Trial teams and external vendors, budget and resource forecasting and providing guidance and expertise in support of advancing specific projects and departmental objectives. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides...

Boehringer Ingelheim Description The (Senior Associate) Directorwill join our motivated and expert team of physicians in the global Cardio-metabolism/Respiratory Therapeutic Area of Patient Safety and Pharmacovigilance at BI, whose priority is the wellbeing of our patients worldwide. This is a highly visible role for an individual with a strong medical/scientific background who is inspired by prioritizing patient safety and who will help BI develop its growing portfolio of innovative medicines. BI believes that our people are our strongest asset - this role will provide you with the opportunity for significant professional development. The (Senior Associate) Director is a key member of global, cross functional product teams that determine the medical-scientific strategy for the respective products. This role is accountable for proactive risk management of assigned marketed and/or investigational compound or a product family on a global level; this includes continuous...

Boehringer Ingelheim Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director/Senior Associate Director, Medical Affairs Strategy Team Member serves as the subject matter expert to create the indication-specific or product-specific Medical strategic framework and prioritized Medical tactics to ensure the success of the...