- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM (Risk Based Quality Monitoring) sets the ... vision and strategy for the RBQM function within R&D. Reviews and provides guidance to RBQM projects. Accountable for the quality and timeline for all RBQM deliverables. Promotes, oversees and is accountable for innovation, standards, processes and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Senior Director is responsible for providing leadership, strategic direction and execution of ... Department.Eisai Salary Transparency Language:The base salary range for the Senior Director , HEOR & RWE - Field-Based is from :247,600-325,000Under current… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Director (Sr. Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new ... medicines span all phases of clinical development (pre-clinical to post-licensure). The Senior Director will manage the entire cycle of late-stage clinical… more
- Formation Bio (New York, NY)
- …to patients faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls ... (CMC) activities related to biologic product development at Formation Bio. This is a strategic and execution-focused leadership role, responsible for advancing large molecule programs from early development through commercialization. You will oversee internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Sr. Director , Data Quality and Integrity (Global R&D & PV QA) ensures high ... process improvements. Collaborating with the Global QMS eCompliance team, the director oversees QA plans, promotes data governance, and engages stakeholders to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts ... with a comprehensive and all-encompassing approach to coordinate activities, under the leadership of the Head of Functional Excellence, across key functions to improve the benefit-risk in patients treated within the oncology compounds throughout the course of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... while driving results.Collaborate with internal and external stakeholders Interact with senior MA/functional leadership teams to ensure Quality is consistently and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Responsibilities:Operational Strategy:Align with the Head of Clinical Development Operations or Senior Director , Clinical Operations on plans for successful ... areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for Development : Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to cross-functional teams on US/EU RA ... Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging… more
- Merck & Co. (Rahway, NJ)
- …our existing and pipeline products to produce safe, effective, innovative medicine.The Senior Principal Scientist/ Senior Director is responsible for protocol ... meetings and preparation of manuscripts for publication in peer-reviewed journals. The Senior Director will also contribute to establishing Vaccine Clinical… more
- Formation Bio (New York, NY)
- …own the IP function for our rapidly growing pharma company. Reporting to the Senior Director , you will operate autonomously to create and execute proactive IP ... strategies that add value both to our existing and future assets. This role is essential in enhancing our diligence efforts and driving successful asset negotiations in a competitive, evolving market.Responsibilities IP Strategy & Execution: Develop and lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary:The Associate Director , Oncology Value & Market Dynamics Training Manager is responsible for ... to access for patients across our portfolio of products. The Associate Director will develop, in partnership with other key stakeholders, innovative solutions for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …4+ years of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong ... expertise in GxP regulations, CSV, 21 CFR Part 11, Annex 11, GAMP 5, and data integrity - Required Deep understanding of IT system architecture, cloud solutions, integrations, and cybersecurity in regulated environments - Preferred Strong strategic thinking,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …governance modelLead training related risk analyses and escalate them to senior leadership in GQAResponsible for development, oversight, and maintenance of GQA ... training programs to ensure cross-functional transparency and consistencyEnsure necessary support is provided to QA functions to develop training curriculums and conduct them in line with the overarching training strategiesDocument and record management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability to travel ... up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Executive Director , Head of Center of Excellence (CoE), Global Medical Safety will ... resources for key programs. The role will also provide senior safety leadership and guidance on complex issues across...other departments across the company to ensure alignment. This senior role will involve close cooperation with other CSPV… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares ... material for KOL interactions on a program based need; Involvement with in-licensing and acquisitions on individual due diligence activitiesQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productive work environment. This pivotal position will report directly to the Senior Director of Operations.Key Responsibilities Champion and lead the employee ... engagement program to cultivate a vibrant culture that empowers and inspires every employee, enhancing their experience and commitment to the company's shared vision.Craft and execute inspiring programs that empower our pursuit of Strengthening Leadership… more
- Eisai, Inc (Nutley, NJ)
- …oversee the Data Review programming and JReview within IODS. Reporting to the Assoc. Director of Clinical Programming is the senior level highly technical SAS ... this is your profile, we want to hear from you. The Associate Director , Clinical Programming must have expertise in addressing technical challenges in the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (Distinguished Scientist) has primary responsibility for the planning and directing of clinical research activities involving ... Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area. The Executive Director will manage and oversee the entire cycle of late stage clinical… more
