- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …governance bodies.Triage, resolve or escalate study issues /risk mitigations to the Operations Program Lead and study team leader .Ensure adherence to ... mitigation plans.Monitor study budget against trial progress and bring deviations to the Operational program Lead and study team leader . Review and approve… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesStudy Strategy: ... meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase... related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program . This Clinical Science ... and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase... Lead will be responsible for overseeing multiple program -level CS Asset Leads who are managing a team… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical ...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader (ITL-ISTL)ResponsibilitiesMedical ... meeting and represents clinical /TMCPStudy Planning and Execution: Clinical Study Lead (CSL) for large Phase... Related: Integrated Study Team (IST) representative or IST leader on study team; Responsible before senior … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL)Study Planning and Execution: Provides input on ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Lundbeck (Bothell, WA)
- …Lundbeck Biopharmaceuticals is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development of novel therapeutic ... to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding of… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle… more
- Merck & Co. (South San Francisco, CA)
- …area's biomedical community, our research ranges from exploratory biology to early clinical development. We work on diverse modalities - small molecules, peptides, ... scientist for our Modeling and Informatics group. As a Senior Scientist (R3), you will be part of a...and deep learning to problems of biological interestExperience with lead identification and lead optimization of diverse… more
- Eisai, Inc (Nutley, NJ)
- …provides strategic development, planning, implementation, and oversight of Phase IV clinical trial programs within the Medical Affairs department. She/He utilizes ... in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The ... research areas centered around rare diseases and immune disorders. Summary The Global Team Leader , is a senior , cross-functional leader in Daiichi Sankyo's… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... and monitors adherence to administrative policies and procedures. The HCP experience lead has a team reporting to them potentially inclusive of hcp experience… more
- Merck & Co. (Rahway, NJ)
- …in both manufacturing and research divisions to assume the following responsibilities:The leader will advance the purpose and aspiration of our Company's digital ... (Chemistry, Manufacturing, and Controls) CMC program to set the foundation for a digital continuum...(DCRC) Steering Committee and Executive Sponsors, Digital manufacturing CMC leader will be accountable for leading the digital technology… more
- Merck & Co. (Rahway, NJ)
- …technology, characterization, and design verification. This role will work alongside the device program lead , who is responsible for leading the device working ... Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …HCP marketing strategy and KOL engagement strategy, overseeing speaker program and omnichannel execution, and measuring marketing effectiveness. They will ... area vision and message.RelationshipsReports to HCP / KOL Strategy Lead . Collaborates with cross-functional teams, including sales, marketing, medical affairs,… more
- Merck & Co. (North Wales, PA)
- …This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one or more ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Novo Nordisk Inc. (Boulder, CO)
- …and Cambridge reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct ... you ready to make a difference? The Position The Senior IT Engineer I - Labs will be responsible...in Boulder, CO and reports to the Lab IT lead in Lexington, MA. Additional internal stakeholders include IT… more
- Merck & Co. (North Wales, PA)
- …Responsibilities: -Portfolio and Project Management (~50%)Responsible for aggregating individual program information to a portfolio viewEstablish robust CMC and ... clinical stakeholder interfaces to maintain a pulse on all...tools, dashboards, and business systems.Manage cross divisional workstreams and lead or input into improvements to processes / templates… more
