- 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)
- …skills, with the ability to effectively collaborate with diverse stakeholders. Solid understanding of software development processes and methodologies.Ability ... vendors.Drive and influence the technology and innovation strategic roadmap for the clinical end to end data flow in partnership with functional stakeholders,… 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)
- …US and Global Brand Team, and US Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic discussions. ... Cycle Management. Leads the team for this compound.Responsibilities- Responsible for the development of the USOMA strategy and medical objectives for the assigned… 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
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking Manufacturing Lead Operator as part of the Technical Operations team based in Raritan, ... operations team responsible for production of autologous CAR-T products for clinical and commercial operation in a controlled current Good Manufacturing Practice… 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
- 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
- Merck & Co. (North Wales, PA)
- …a clinical trial.May serve as the clinical trial team leadMay lead team in key study planning, development , and execution elements (eg, data ... study objectives.Accountable for managing any study specific partners and/or vendors. Solid knowledge of clinical research regulatory requirements (eg, GCP… 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
- 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
- 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. (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
- AbbVie (North Chicago, IL)
- …scientific activities with internal stakeholders as they relate to ongoing projects. May lead clinical development contributions to due diligence or other ... have ownership of the design and implementation of multiple clinical development programs in support of the...Teams (ADTs) and ADT Leadership Boards (ALBs), and who lead Clinical Strategy Teams (CSTs) and … more
- BeiGene (San Mateo, CA)
- **General Description:** The Executive Director, Clinical Development will effectively lead BeiGene clinical assets through successful development of ... early and late phase clinical development strategies and deliverables in partnership with multiple functions...regulatory submissions and other regulatory processes. + Play a lead role in the development and implementation… more
- AbbVie (North Chicago, IL)
- … Leader, designs, conducts and reports clinical trials in line with the development , regulatory and commercial strategy. May lead 0-5 employees in a matrixed ... when working under licensing agreements. Responsibilities: Assists in the design of clinical studies and clinical development plans. Responsibilities may… more
