- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of managing multiple direct reports. ResponsibilitiesOperational StrategyAlign with the Head of Clinical Development Operations or Senior Director , ... 1-3 clinical trials at the study and program level. Responsible for clinical program...the associated budget meet the needs of the overall development plan agreed to by the Global Project Team… more
- Insmed Incorporated (Bridgewater, NJ)
- …Protocol Assessment (SPA) Agreements in compliance with Clinical Development Plans and regulatory requirements.Provide program level medical oversight ... in New York™, and Best Workplaces for Millennials™ lists.OverviewTheDirector, Clinical Development will play an important role...This opportunity will require a focus on all the clinical aspects of the upcoming HS program .… more
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program...+ 6 years OR PhD/PharmD + 2 yearsPharmaceutical and/or clinical drug development experience. Degree in life… more
- Insmed Incorporated (San Diego, CA)
- …for the development of, and the oversight for execution of clinical studies milestones to support company budgets, and quality standards.Ensure the clinical ... lists.OverviewThe primary responsibilities are to manage all aspects of clinical operations including study planning, financial oversight, project deadlines and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical Development in Project Teams, ... representative: Creates early development plan and contributes to overall development Strategy; Develops program biomarker strategy; Achieves endorsement for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(short-term, mid-term, long-term)These will include but not limited to Group Heads in Clinical Development , Asset & Portfolio Management, Global Clinical ... and aligned guidance to asset teams to enable seamless tumor-specific clinical development and strategyResponsibilities - Accountable for developing the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an advanced degree required.6-9 years of experience with a bachelor's degree required. Clinical development or post-marketing experience to be able to apprehend ... as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, in order to proactively perform safety surveillance and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …veterans and people with disabilities. Summary The Associate Director , Clinical Data Standards, is responsible for the development , maintenance, and ... pipeline.Proactively identify Data Standards gaps and resolve issues related to clinical data standards development throughout the trial lifecycle.Standardize… more
- Insmed Incorporated (Bridgewater, NJ)
- …New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director of Clinical Pharmacology role within Clinical Development organization will ... and expertise to support assigned clinical pharmacology projects in the clinical development programs for an expanding portfolio of small, biological and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountability for operational study-level timeline, cost, and quality deliverables.Lead the development of the clinical study plan including critical path ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the...is complete and accurate for assigned stud(ies).If assigned, Associate Director , Clinical Operations may act as the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one ... interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents;… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key ... matters; Supports marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …required along with a minimum of 5 years of team leadership in clinical development /trials Experience leading cross-functional teams in the execution of ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …that support the clinical development and regulatory requirements of a clinical program . The Director will provide high level strategic input into ... NJ. We support programs from early research through late-stage clinical development . We are building for the...development plans, study designs, and regulatory submissions. The Director will provide direction and mentoring to other members… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , Commercial Learning & Development , will be a key member ... the Commercial Effectiveness organization, primarily responsible for the successful development , delivery and management of comprehensive training (ie: product,… more
- Insmed Incorporated (Bridgewater, NJ)
- …collaborative partnerships with the cross-functional Insmed team (Medical Affairs, HEOR, Clinical Development , Advocacy, Commercial and Market Access) as well ... in alignment with business strategy, medical affairs strategy and Insmed clinical development programsManage external vendors/medical agencies assisting with… more
- Tris Pharma (Monmouth Junction, NJ)
- … Director provides leadership, direction and medical expertise for company’s clinical development programs specifically focused on the treatment of Pain. ... development /delivery and execution oversight of the Pain clinical development strategy and clinical ...programs and assists, as appropriate, in other therapeutic area program development (ie, substance use disorders, ADHD,… more
- Eisai, Inc (Nutley, NJ)
- …EMRs, patient charts, administrative claims datasets.Previous RWE experience in clinical /medical development , and interactions with regulatory authorities is ... and oncology, with a strong emphasis on research and development . Our history includes the development of...is your profile, we want to hear from you.The Director is responsible for developing RWE strategies for assigned… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Insmed Incorporated (Bridgewater, NJ)
- …with the cross-functional data generation team (Medical Affairs, HEOR, Biometrics, Clinical Development ) and engage with healthcare professional experts and ... Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Scientific Publications is a core member of Medical Strategy and… more
