- Genmab (Plainsboro, NJ)
- …of life-cycle management is preferred. A solid understanding and experience in drug development including early and late development is highly preferred. ... this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the assigned… more
- Merck & Co. (Rahway, NJ)
- …and approvals to support continued product supply.Participate - in early and late development programs, as well as departmental and cross-functional initiatives ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …operational coordination and management to drive strategies and activities for early and late phase drug development candidates within the team to support ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...defined based on the project needs and the respective development stage of the project. The CMC Lead will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... Safety & Pharmacovigilance (CSPV) for assigned products. This position drives/leads the development and maintenance of the CCDS, US and EU labeling, and manages… more
- Amgen (Washington, DC)
- …and transform the lives of patients while transforming your career. ** Medical Sciences Director - Late Development Oncology** **What you will do** Let's ... To support that effort, the Oncology Late Development Group is looking for a Medical ...Medical Sciences Director will contribute to late phase clinical development of oncology. They… more
- Pfizer (South San Francisco, CA)
- **ROLE SUMMARY:** The medical director provides Clinical Development leadership and expertise on clinical trials, including overseeing the design, conduct, ... and analysis. The medical director works closely with other functions...other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development… more
- Takeda Pharmaceuticals (Boston, MA)
- …global team of managers and scientists and their teams in the field of analytical development in the field of late stage synthetic molecules + Oversee and manage ... late stage analytical development for clinical trial material efforts across three main...US based employees may be eligible to participate in medical , dental, vision insurance, a 401(k) plan and company… more
- NextEra Energy (Juno Beach, FL)
- **Project Director , Late -Stage Development (West Region)** **Date:** Jan 23, 2025 **Location(s):** Juno Beach, FL, US, 33408Sacramento, CA, US, 94203San ... to you? Join our world-class team today **Position Specific Description** The Project Director , Late -Stage Development (West Region) will have the primary… more
- AbbVie (Jersey City, NJ)
- …pharmacy, clinical development , and discovery + Works closely with Executive Medical Director to establish safety strategy for each indication and across ... Medical Directors: performance and talent management, coaching and development . + Assumes responsibility for coordinating and overseeing safety related… more
- Bristol Myers Squibb (Brisbane, CA)
- …leaders. The successful candidate will have prior therapeutic area and late development clinical experience in biotech/pharma organizations interacting with ... are not limited to, the following:** + Designs and implements program-specific late development biomarker/translational plans, responsible for aiding in creation… more
- AbbVie (Jersey City, NJ)
- …the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead ... with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen,… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …(edaravone) oral suspension in 2022. The company handles research, clinical development , sales, marketing, medical affairs, and business development ... respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several… more
- Catalent Pharma Solutions (Philadelphia, PA)
- …oral solid dose manufacturing and Rx softgel technologies. The Regional Business Development Director is accountable for achieving Revenue, Sales, Quotes and ... Job Description **Regional Director , Business Development - Pharma Product...and annual performance review and feedback process + Competitive Medical , Dental, Vision and 401K + 19 days PTO… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we ... Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW: Director , Biostatistics** Position can be REMOTE or office based in Parsippany,… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** Join Takeda as a Sr. Scientist, Analytical Development (AD), Late Stage Development where you will independently ... business and support in-silico and automation initiatives. As part of the Analytical Development team, you will report to Director , Analytical Development .… more
- AbbVie (North Chicago, IL)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Executive Medical Director is responsible for the safety strategy for Hematology ... supporting the hematology in the Oncology TA. The Executive Medical Director will be the oncology safety...with and influences other cross functional departments (eg Clinical Development , Regulatory Affairs, Medical Affairs), as needed,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Clinical Development - Respiratory Date: Jan 21, 2025 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job ... role to support the growth within the respiratory clinical development program at Teva! The Senior Director ,...in consultation with Global Drug Safety and Pharmacovigilance, SVP Late Clinical Development and the Disease Area… more
- Novo Nordisk (Lexington, MA)
- …in Lexington, MA and Plainsboro, NJ. We support programs from early research through late -stage clinical development . We are building for the future, creating a ... ready to make a difference? The Position The Associate Director is an expert in medical writing...Director will provide high level strategic input into development plans, study designs, and regulatory submissions. Relationships The… more
- Sumitomo Pharma (Columbus, OH)
- …website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. **Job Overview** The Director , Medical Affairs Strategy (Hematology/Oncology) will be a key ... member of the Medical Affairs team reporting to the Executive Director...function. This individual will lead program coordination with Clinical Development leadership to ensure alignment between Medical … more
