- Jazz Pharmaceuticals (Palo Alto, CA)
- …please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief Description:The Clinical Development Lead , Oncology, BTC (Biliary Tract ... a key Oncology asset for BTC and GEA. The Clinical Development Lead will play...required. Board certified Oncologist preferred.Higher postgraduate degree eg, PhD preferred. Clinical and/or development experience in solid… more
- Merck & Co. (Rahway, NJ)
- …programs including those new to the organization therefore requiring someone who has built and lead clinical development plans from the ground up. They will ... Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development , Respiratory will focus on...to approved strategies and plans. They will require a solid understanding of the disease area, the functions and… more
- Merck & Co. (Rahway, NJ)
- …with company requirements and regulations are delivered and sustained. The Sr CCQM Lead supports large to medium size country/cluster clinical trial operations ... Quality Management (RCQM), and in collaboration with the Clinical Research Director(s), the Sr CCQM Lead ...Clinical Quality Managers (ACCQMs) as well as talent development in collaboration with RCQM. -The role requires the… more
- Merck & Co. (North Wales, PA)
- …/scientific execution of clinical protocol(s). This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical ... Clinical Director.Other responsibilities include: Collaborating cross-functionally in the development of Protocol and related study materials (eg, ICF… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities. Summary The Associate Director, Clinical Data Standards, is responsible for the development , maintenance, ... Oncology Therapeutic area with Medical / Scientific acumen in Solid and Liquid tumors, understanding of the CDISC (SDTM,...identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role...technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Responsible for teaching DSI Selling Skills and coaching for progressive skills development ; Assessing and training product knowledge and clinical selling; ... around rare diseases and immune disorders. Summary: Manager, Sales Training and Development - Oncology serves as the training subject matter expert with their… more
- Merck & Co. (North Wales, PA)
- … in the cross-functional teams for the strategic planning and execution for product development -Is involved in clinical development planning to ensure that ... leadership and support for related drug/vaccine projects in Late Development Statistics.Interacts with Clinical , Regulatory, Statistical Programming, Data… more
- Merck & Co. (Rahway, NJ)
- … trial.- May serve as the clinical trial team lead - May lead team in key study planning, development , and execution elements (eg, data management ... Bachelor's degree + 5 years OR Master's + 3 years Pharmaceutical and/or clinical drug development experience OR PhD/PharmD Degree in life sciences,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …therapeutic compounds. This includes working with scientists in Research, Translational Science, Clinical Development , in addition to colleagues in QCP. QSP ... script-based analysis packages to generate clinically relevant hypotheses to inform clinical development programsStay informed with emerging literature and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of all phases of drug development , including early and late phase clinical development and submission preferred- Solid background in applied statistics ... submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory...the macros or tools that will facilitate programing efficiency, lead the macro or tool development by… more
- Lundbeck (Bothell, WA)
- …methods to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough ... is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development... development programs (from early to late phase clinical development ) Author and review SOPs, … more
- Novo Nordisk Inc. (Boulder, CO)
- …a new laboratory completed in 2021 to support analytical and process development , the CMC team works alongside Quality, Regulatory, Technical Operations and RNAi ... Early Development professionals at our Boulder, Colorado facility and works...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …direction of the Senior Director, GMA Oncology (Global Medical Affairs team lead for compound), is responsible for assisting with defining compound/program medical ... Medical Affairs projects within gynecological oncology indications.Responsibilities:- Leads the development and execution of the Global Medical Affairs strategy for… more
- Merck & Co. (Rahway, NJ)
- …will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of our company's Research & Development Division ... and company strategy.Providing quality advice to stakeholders creating optimal development , commercialization, and drug/delivery device supply strategies-Building our leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Manage CRO to ensure high quality compound and multi-compound level deliverables. Lead the development of global harmonization of programming processes ... of analysis data sets and tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this… more
- Merck & Co. (South San Francisco, CA)
- …direct reports and peers. Solid understanding of drug discovery and clinical development .Working knowledge of biomarker discovery, translational research, and ... and across the network, as well as collaborating with key opinion leaders in academia. Lead the development and implementation of in vitro and in vivo assays… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …executing on a global product(s) strategy, which integrates scientific rationale, clinical development , nonclinical development , regulatory, medical, ... activities that are executed in matrix and functional channels (eg clinical development , technical operations, commercial, regulatory).Mentor team members,… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …Oncology, GMA will be the voice of Medical in the Global Product Team, Clinical Development and Functional Matrix Teams to support franchise related decisions ... Generation Plans (IEGPs) for all Oncology assets in late clinical development or on market, covering global...of 5 years of experience in Medical Affairs in solid tumors and hematological malignancies. Clinical experience in… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- … programs.Collaborate with researchers and thought leaders in the planning of clinical development programs and the publication of study data.Present study ... and follow @JazzPharma on Twitter. Brief Description: The Director, Oncology Early Development Biostatistics is the statistical lead on Oncology Early … more
