- Eisai, Inc (NJ)
- …profile, we want to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and support activities related to the ... development.#LI-TS1Eisai Salary Transparency Language:The base salary range for the Associate Director, Clinical Outsourcing is from :157,200-206,300Under… more
- Merck & Co. (North Wales, PA)
- …activities.Job Responsibilities Responsible for the clinical /scientific execution of clinical protocol(s).Serves as the lead clinical scientist ... of Phase 1-4 clinical studies. Under the direction of the Program Lead , you will collaborate with global, cross-functional team members including clinical … more
- Merck & Co. (North Wales, PA)
- …and statistical analysis methods fundamental to effective pharmaceutical R&D.- The Clinical Safety Statistics (CSS) group within BARDS supports proactive assessment, ... statistical representative and core member in the Risk Management Safety Teams.- Lead and provide statistical support for related drug/vaccine projects in … more
- Merck & Co. (Rahway, NJ)
- …as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. Actively develops and ... expands the territory for clinical research, finding and developing new sites. Participates in...and ability to work within these guidelines.Demonstrated ability to mentor/ lead .Hands on knowledge of Good Documentation Practices.Proven Skills in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies, conduct hands on ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead ; supports Phase 2/3 clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Merck & Co. (Rahway, NJ)
- …your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production with respect to device ... device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes.-- This position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible for the management of technology transfer of the manufacturing ... supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site-Launch activities and associated teams for… more
- Merck & Co. (North Wales, PA)
- …plan(s) and manages relationships with both internal and external groups. The Associate Director Pub Manager is expected to: Lead cross-functional Publication ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central...of the therapeutic area, and scientific expertise, they will lead the development of comprehensive publication strategy and plans… more
- Merck & Co. (Rahway, NJ)
- …existing and pipeline products to produce safe, effective, innovative medicine.The Global Clinical Data Standards Vocabulary Specialist, Associate Director, is a ... standards and associated processes for growth opportunitiesThe Vocabulary Specialist may lead or participate in:Internal clinical data standards forumsStandards… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …of developing innovative cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy program. ... in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based… more
- Catalent (Manassas, VA)
- Associate Director, Regulatory Affairs Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in ... every patient, consumer and Catalent employee. The primary duty of the Associate Director, Regulatory Affairs is to support regulatory strategy for product… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at ouor company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the ... Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical strategies and for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …target prioritization, therapeutic modality selection, biomarker characterization and early clinical trial designInteract with, and possibly lead , ... areas centered around rare diseases and immune disorders. Summary The Associate Director, Quantitative Systems Pharmacology (QSP) will work within the Quantitative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …opportunity employer including veterans and people with disabilities. Summary The Associate Director, External Data Management, is accountable for the end-to-end ... delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors… more
- Merck & Co. (North Wales, PA)
- …Director, Pulmonary Arterial Hypertension (PAH) Payer Marketing & Access Strategy As Associate Director, PAH & Rare Disease Payer Marketing, you will be an ... of US market access strategies and tactics and serve the primary segment lead for US Payers, Pharmacy-Benefit Managers (PBM), and employers.This role will require… more
- Merck & Co. (Boston, MA)
- …and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct ... Job DescriptionThe Associate Vice President (AVP)/Therapeutic Area Head, Immunology Translational Medicine, will be responsible for leading the Translational… more
- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on drug product. Additionally, experience in medical ... data integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform.-The position will be heavily involved in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …build up standard on SDTM/ADaM datasets, and TFLs.Responsibilities- Supporting project lead on outsourced projects, act as statistical programming subject matter ... to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting-… more
