- Daiichi Sankyo, Inc. (Bernards, NJ)
- …bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to internal ... Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine...trial progress and bring deviations to the Operational program Lead and study team leader .… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be responsible for overseeing multiple ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase...core or extended member of the Disease Area Strategy Team (DAST), the CS Group Leader will… more
- Merck & Co. (Rahway, NJ)
- …Our company's Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will manage the entire cycle ... design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director may be responsible for:Evaluating pre- clinical … more
- Merck & Co. (South San Francisco, CA)
- …partnerships to drive portfolio development and progression. If you are a highly motivated leader and team player with a proven tracker record of success in ... The successful candidate will have direct line management of a research team responsible for the design, execution, and interpretation of complex in vitro/ex… more
- Merck & Co. (Rahway, NJ)
- …At our company, we're shaping the future of health. We're seeking a Clinical Database Developer who will be instrumental in creating and developing clinical ... role provides a unique opportunity to contribute to a team that is delivering innovative solutions for the prevention...Your primary role will be to create and develop clinical databases and data transfer files, ensuring they align… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PK-PD and Pop PK-PD concepts and independently performs PK-PD analyses, functions as Study Team Leader for Phase 1 Clinical Pharmacology studies, and ... Biopharmaceutics studies and model-based drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team . In addition, he or she will interact with the Companion Diagnostics Lead , Non- Clinical Research, Medical Affairs and other stakeholders to support the ... defining key scientific questions and plan. Align closely with the Senior Translational Strategy Lead .Construct translational plan documents, biomarker data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …alignment of HCP brand objectives, KOL engagements, and strategies. The HCP / KOL strategy lead has a team of HCP and KOL strategists reporting to them. ... based on real-world results. We are building an intentional team culture that is made up of diverse skillsets,...with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... function. The incumbent will champion model-based drug development as an active team member of clinical and development teams.ResponsibilitiesResponsible for all… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a possibility of working in collaboration with a strategic alliance partner.Responsibilities- Co- lead a cross-functional Evidence Generation Team (EGT) for the ... other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director, Global Oncology Medical Affairs, Evidence Generation role is… more
- Aequor (Thousand Oaks, CA)
- …in the Pivotal, Life Cycle Management and Commercial space working with the Operations Leader and the Product Delivery Team . The Sr. PM will manage ... Senior Project Manager - CMC Integration Project Management...for a Sr. Project Manager in our CMC Integration team within Operation Products Advancement in Process Development. The… more
- Merck & Co. (North Wales, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive Director in ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines,...respect, encouragement and teamwork. As part of our global team , you'll have the opportunity to collaborate with talented… more
- Merck & Co. (North Wales, PA)
- …including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will also be ... providing input into research and business development priorities and prioritization of clinical assets.-May serve as the senior liaison for relevant… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... The PositionThe Novo Nordisk Real World Evidence (RWE) / Clinical Data Science & Evidence (CDSE) - Fellow is...coordinate other activities including but not limited to cross-functional team meetings, project team meetings and observational… more
- Merck & Co. (Rahway, NJ)
- …Rahway, New Jersey and reports to the FLEx Sterile Expansion Business Lead within Pharmaceutical Operations and Clinical Supply.- Education Minimum Requirements ... located in Rahway, New Jersey includes a state-of-the-art sterile drug product cGMP clinical supply manufacturing facility known as FLEx Sterile that is currently in… more
- Eisai, Inc (Boston, MA)
- …and interest in coaching and mentoring less experienced MSLs. Ability to lead and motivate team members without a direct reporting relationship.Ability ... we want to hear from you. Job Summary The Senior Medical Science Liaison (Sr.MSL) is a field-facing representative...and its hhc mission; b) provide key scientific and clinical information about Eisai's products; serve as a conduit… more
- Merck & Co. (San Diego, CA)
- …antibodies and other biologics modalities to support candidate selection and pre- clinical development of therapeutic programs. Lead analytical characterization of ... Job DescriptionOur company is a global health care leader with a diversified portfolio of prescription medicines,...and Development Division in San Diego is a cross-functional team (Discovery Biologics, Immunology, and Data Science) with the… more
