- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... experience in Regulatory Affairs. A solid understanding and experience in oncology drug development is highly preferred. Strong project management skills. Prior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …preferred Minimum of 8 years total pharmaceutical/related industry experience in drug development required Demonstrated knowledge of global regulatory ... meetings with regulatory agencies, including the FDA Experience with rare disease drug development , innovative trial design and/or expedited regulatory pathways,… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where you… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... AI and Digital Technologies at Genmab! With our rapid development and implementation, you'll have the chance to harness...Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products.… more
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Genmab (Plainsboro, NJ)
- …to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial ... development and management of the trial budgetPlan, implement, and...next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody- drug conjugates. To help develop and deliver novel antibody… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is ... rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support overall CMC ... plan.- Represent CMC development project teams on cross-functional drug development project teams with a predominately operational focus; ensuring… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the ... meeting or teleconferences with Health Authorities- Global BDO Strategy to Improve Drug Development : Primarily participates and may occasionally lead moderately… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partners to ensure high quality coding deliverables are on time to support drug development processes and global submissions. This position also partners with ... integrity, and timelines for assigned studies and escalates issues to the Associate Director of Medical Coding to gain resolution. Functional Expertise:Study… more
- Bristol Myers Squibb (Princeton, NJ)
- …priority, challenging, and personally fulfilling strategic initiatives. **Position Summary** Support the development and execution of Drug Development 's (DD) ... role will require experience with Innovation, emerging technologies, product development / roadmaps, transformational / change leadership, and executive… more
- Merck (North Wales, PA)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... **Job Description** **Job Description:** The drug development Project Manager is part...of our company. ** ** **Position Description/Summary:** The GPAM Associate Director , Project Manager, is a core… more
- Merck (West Point, PA)
- …diseases. Our company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development . Vaccine Drug Product ... The Director will report to the Executive Director of Vaccine Drug Product Development...be responsible for a team of 10-20 senior and associate level scientists. The incumbent will be responsible for… more
- Bristol Myers Squibb (Princeton, NJ)
- … and successful marketing authorizations across the globe. PCO "is looking for a Scientific Associate Director to join the Dev DMPK group that is an expert in ... ADME and pharmaceutical drug development of small molecule and protein therapeutics. In this role, you will represent the Dev DMPK function on cross-functional … more
- Merck (West Point, PA)
- …Metabolism & Bioanalytics (PDMB) is seeking a curious and collaborative Scientific Associate Director for our growing Translational PK/PD organization. The ... Translational PK/PD Associate Director is an expert mathematical modeler...responsibility and independence in a similar role in pharmaceutical drug development or academia setting + Experience… more
- Merck (West Point, PA)
- …component of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... Associate Director will work with scientists within...trial design and Go/No Go decisions + Framing critical drug development questions for optimizing model-informed … more
- WuXi AppTec (Plainsboro, NJ)
- …our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates ... ("TIDES" drug ). We greatly simplify the TIDES drug development by providing all discovery, CMC development , and the entire manufacturing supply chain… more
- Bristol Myers Squibb (Princeton, NJ)
- …implementation of technical solutions for integrating, analyzing and reporting clinical data. Associate Director drives the development and implementation of ... & Data Sciences (GBDS), with external vendors and members of cross-functional development teams. Associate Director , Statistical Programming, independently… more
- Penn Medicine (Hamilton, NJ)
- …Our employees shape our future each day. Are you living your life's work? Associate Medical Director Summary: + To provide high quality comprehensive clinical ... participates in the psychiatric on-call system. In collaboration with the Medical Director for the Outpatient Site, provides clinical and administrative oversight of… more
