- Merck & Co. (North Wales, PA)
- …medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of clinical development, ... design, placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... Integrated Data Review PlanAccountable for the assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...senior leadership at DP0. Surface expert knowledge on safety biomarkers that might be used in preclinical and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …In this role, the incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to ... make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree...design and execution of clinical trials, the drafting of medical / scientific documents, safety monitoring, and data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... around rare diseases and immune disorders. Summary A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an ... Review Plan- Accountable for the assessment of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports PV Operations' medical review function. This position supports a senior physician in evaluating and mitigating safety signals as they arise. ... medical knowledge to aid the SMT's signal identification efforts. Safety Expert - Signal Evaluation: Assists manager in assessing...of the NDA, CSR, and IB. May review any safety submissions for medical accuracy. Qualifications: Successful… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and regulatory… more
- Eisai, Inc (Nutley, NJ)
- …planning and supportive tactics for assigned therapeutic area. Under the direction of the Senior Medical Director , this role will be responsible for working ... Affairs Strategic Plans: Under the direction of the Senior Medical Director , work with...other internal key business processes. Responsible for approval of medical and scientific content of Regulatory, Safety ,… more
- Eisai, Inc (NJ)
- …and make a difference. If this is your profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for ... medical advisory boards, and scientific communication/publication components of overall medical operating plan. The Medical Director provides strategic… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... actionable insights to guide the business. Relationships Reports to the Director , MAPA Insights. Internal relationships include close interactions with Market Access… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Analytics functions and translating into business impact. Relationships Reports to the Senior Director , Enterprise Functions Insights Lead with direct management ... future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... of external business development opportunities. Relationships Reports to a Director in Strategic Finance. Internal interactions include stakeholders across the… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director , Clinical Development. Title and salary commensurate ... pharmacology and regulatory teamsReviews data generated during study execution to formulate medical understanding of safety and efficacy resultsActs as … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The ... lives for a living. Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams to manage… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director for Operations Compliance and Investigations Managementas part of the Technical ... Operations team based in Raritan, NJ. Role Overview The Associate Director for Operations Compliance and Investigations Management will provide strategic direction… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …responsible for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science (CS) ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director - Safety Surveillance, ... make a difference?The Position This leadership role is accountable for developing the safety strategy, major safety deliverables for assigned programs within the… more
