- Novo Nordisk Inc. (Plainsboro, NJ)
- …in Lexington, Watertown, Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development . Here, we are ... internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... About the Department Our East Coast Global Development Hub brings together the best minds in...functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development . We are building ... will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, US East Coast Development...decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …related to promotional materials or claims Engage with commercial business partners early in the development of promotional materials to enhance efficiency, ... 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
- Organon & Co. (Plymouth Meeting, PA)
- … Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development ... director may represent the TMED function in asset development teams (ADT) across the portfolio including drug candidates...working knowledge of regulatory guidances and requirements pertaining to early clinical development including … more
- Bristol Myers Squibb (Princeton, NJ)
- …The Director of Biospecimen Management for Cell Therapy & Early Oncology will efficiently and independently perform the duties and responsibilities outlined ... below. Reports to the Senior Director , Biospecimen & Imaging Management HOCT. **Duties/Responsibilities:** + Lead...preferred. + Minimum 7 years of global experience in clinical drug development , biospecimen management, or related… more
- J&J Family of Companies (Titusville, NJ)
- Medical Director , Clinical Development - Psychosis Spectrum Illness - 2406220383W **Description** At Johnson & Johnson, we believe health is everything. Our ... impact health for humanity. Learn more at https://www.jnj.com/. The Early Development (ED) Project Physician Psychosis Spectrum...Project Physician provides input to translational discovery and the clinical development plans, works on the … more
- Bristol Myers Squibb (Princeton, NJ)
- …for the Development Team and is responsible for navigating the overall clinical development plan for complex programs that have a large impact on ... and ensures adherence to GCP and compliance obligations for clinical conduct + Represents Clinical Development...of BMS + Partner and interact with colleagues from Early Development who design and implement first… more
- Merck (West Point, PA)
- …Process Research & Development within DSCS: organization is responsible for process development and early clinical supply manufacture of drug substance ... **Position Description:** ** Director , Analytical R&D and Process R&D,** ** Development Sciences & Clinical Supply Finance** The Director will oversee a… more
- Bristol Myers Squibb (Princeton, NJ)
- …supported. The CP&P team interacts with discovery and translational scientists, project leadership, early and late clinical development teams and commercial ... and pharmacometric support for all pipeline assets throughout the clinical development lifecycle. Composed of pharmacologists, pharmacometricians, data… more
- J&J Family of Companies (Spring House, PA)
- …biologics industry process development strategies and best practices as applied from early development to late stage and commercialization * S/he must be ... Associate Director , Cell Therapy Process Development -...of a cross-functional teams supporting pre- clinical and clinical programs, focused on CMC development . Primary… more
- Novo Nordisk (Plainsboro, NJ)
- …of treatments for MASH and ALD and oversee a robust pipeline of projects from early research through late-stage clinical development . We are building a ... Director will also assist the Sr. Medical Director in the development and execution of...groups and utilize novel and creative methods to resolve clinical development problems + Work with the… more
- J&J Family of Companies (Trenton, NJ)
- …role. The submission strategist is the primary RegMW interface to the Compound Development Teams (CDTs) at the early stages of submission preparation and ... R&D. Principal Responsibilities: Leadership: + With a focus on clinical scientific content, lead early strategic submission...+ Lead and hold the cross-functional team accountable the development of the clinical storyboard document (eg,… more
- Merck (West Point, PA)
- …clinical trial design, and go/no-go decisions. + Represent QP2 on ophthalmology discovery, early clinical development and late clinical development ... on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for ophthalmologic disorders.… more
- Merck (West Point, PA)
- …to impact strategies and decisions of drug development teams. Finally, the Director mentors or supervises early career scientists to grow their skill-sets to ... on cross-functional teams of experienced scientists to discover and advance the clinical development of novel therapeutic agents for immunologic disorders. More… more
- Lilly (Philadelphia, PA)
- …radiopharmaceutical development and manufacturing. + Partner with key functions (eg Clinical Supply, Clinical Development , Clinical Operations, and ... teams. The individual will provide expertise and leadership in the development and manufacturing of new radiopharmaceutical products working in a fast-paced,… more
- Organon & Co. (Plymouth Meeting, PA)
- …2.7.2 for regulatory submissions. **Responsibilities** + Serve as the Pharmacometrics Lead on early clinical development programs and work in close ... position can be 100% remote in the US** The Director , Pharmacometrics Lead is responsible for devising the program-level...collaboration with ADTs to develop and implement early clinical development plans that… more
- J&J Family of Companies (Spring House, PA)
- …o Mentors and coaches assigned team members to lead sub-teams and other Early Development Programs as required. * Ensures alignment with Leadership and ... development in Immunology is preferred (experience in early development in preferred) The anticipated base...(6084) **Relocation Eligible:** Yes - Within Country **Job Function** Clinical Development & Research & Non-MD **Req… more
- Bristol Myers Squibb (Princeton, NJ)
- …area in collaboration with key stakeholders utilizing risk-based approaches and differentiating early clinical development and late phase strategies. Leads ... be considered towards industry experience + Proficient knowledge of drug development process, clinical trial methodology, regulatory guidance, industry… more
- Organon & Co. (Plymouth Meeting, PA)
- … of Biostatistics will provide critical statistical input and expertise in the clinical development and regulatory submission and be responsible for statistical ... team in supporting ongoing clinical research and interface extensively with Clinical Development , Regulatory teams, and Medical Affairs, among other internal… more
