- Merck & Co. (Rahway, NJ)
- …our external Dx partners.Interface directly with scientists and physicians in discovery sciences, early- stage clinical development, and late - stage ... with global regulatory agencies to provide CDx expertise.Provide CDx input into early- stage oncology programs.Assist in the transfer of assays from in-house… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …concise updates on project statuses and next steps to prepare the Head of Late Stage Oncology Development for upcoming discussions, commitments, and ... as needed; Act as representative for the Head of Late Stage Oncology Development in...within the biotech/pharmaceutical industry required andDemonstrated understanding of the clinical research process and oncology drug development… more
- Merck & Co. (Rahway, NJ)
- …human health.This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.The… more
- Merck & Co. (Rahway, NJ)
- …and accountable for the end-to-end lifecycle management for our company's late - stage multi-tumor assets. This includes the breadth/depth of development ... launches. The Vice President (VP) will work collaboratively with Oncology VP TA heads directly as well as through...of Asset Team Leads who will develop individual molecule late - stage development plans; will work across TA… more
- Merck & Co. (Rahway, NJ)
- …mechanistic PK-PD models and QSP models for decision making in early and/or late - stage clinical development Experience with mechanistic modeling for antibody ... to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late - Stage Development Portfolio. The individual will play a key role in making ... supporting CDx submissions to the FDA and other health authorities globally For late - stage programs, executes the Diagnostic development strategy for a project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …team and serves as ad hoc member to the Global Project Team for late stage projects. This position manages multiple biological developmental projects with ... 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology ," Daiichi Sankyo is primarily focused on providing novel therapies in … more
- Pfizer (New York, NY)
- … trial(s) in support of the development strategy for programs within the Late - Stage Oncology portfolio. **Position Responsibilities** + Maintains current ... scientific and clinical knowledge in the specific therapeutic and disease area(s)... Research experience in the Phase 3/pivotal space in Oncology , ideally on the side of the sponsor. +… more
- Pfizer (New York, NY)
- **ROLE SUMMARY:** The Senior Manager, Oncology Early Stage Clinical Scientist will work collaboratively with the Global Development Lead (and members of the ... team) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or...the GDL. + May support the transition early development clinical programs into late stage … more
- Bristol Myers Squibb (Princeton, NJ)
- …proof of concept trials and will assure a seamless transition into late stage development (Phase II-III trials.)** **Governance Participation and Signature ... and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy** **Key Competency Requirements:** +… more
- Merck (Rahway, NJ)
- …and accountable for the end-to-end lifecycle management for our company's late - stage multi-tumor assets. This includes the breadth/depth of development ... launches. The Vice President (VP) will work collaboratively with Oncology VP TA heads directly as well as through...of Asset Team Leads who will develop individual molecule late - stage development plans; will work across TA… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …on early oncology assets, you may act as the Global Regulatory Lead for early- stage , late - stage , or other programs depending on business needs. You will ... they live or their economic status. **POSITION OVERVIEW:** As a Director, Early Oncology Global Regulatory Affairs, you will develop and execute Oncology … more
- Merck (Rahway, NJ)
- …Dx partners. + Interface directly with scientists and physicians in discovery sciences, early- stage clinical development, and late - stage clinical ... with global regulatory agencies to provide CDx expertise. + Provide CDx input into early- stage oncology programs. + Assist in the transfer of assays from… more
- Merck (Rahway, NJ)
- …mechanistic PK-PD models and QSP models for decision making in early and/or late - stage clinical development + Experience with mechanistic modeling for ... to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field… more
- Merck (Rahway, NJ)
- …health. This position supports statistical programming activities for multiple and/or late stage drug/vaccine clinical development projects. Accountability ... tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and post marketing support.… more
- Bristol Myers Squibb (Princeton, NJ)
- … pharmacology and oncology drug development. + Experience with early and late - stage clinical development, IND and filing dossier + Radiopharmaceutical ... and regulatory perspective to take a project from concept stage to commercialization. + Provide clinical pharmacology...from concept stage to commercialization. + Provide clinical pharmacology expertise to the project team and closely… more
- Bristol Myers Squibb (Princeton, NJ)
- …Research organization that facilitates the transition of drug candidates from early to late - stage clinical development, their approval and life cycle ... on deep understanding of drug mechanism of action and disease segments. Late - stage translational development activities build upon the early work, additionally… more
- Sumitomo Pharma (New York, NY)
- …products in the US, Canada, and Europe, and a diverse pipeline of early- to late - stage assets, we aim to accelerate discovery, research, and development to bring ... products in the US, Canada, and Europe, a diverse pipeline of early- to late - stage assets, and in-house advanced technology capabilities, we aim to accelerate… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …in support of projects and Global Project Teams within Daiichi Sankyo's Early and Late - Stage Development Portfolio. The individual will play a key role in making ... CDx submissions to the FDA and other health authorities globally + For late - stage programs, executes the Diagnostic development strategy for a project under… more
- AbbVie (Florham Park, NJ)
- …as deliverables to relevant Asset Strategy Teams (ASTs) for both early and late stage development program including leading or contributing to: comprehensive gap ... remarkable impact on people's lives across several key therapeutic areas - immunology, oncology , neuroscience, and eye care - and products and services in our… more
