Project Lead, Clinical Supply Planning

5 months ago

Basking Ridge, United States Daiichi Sankyo Full time

Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 120 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for supporting CSO Project Management Leads by developing and updating Study Supply Plans, managing various work streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential functions of this position. However, it in no way states or implies that these are the only duties you will be required to perform, nor is it intended to be such a listing of the skills and abilities required to do the job. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or is an essential function of the position.

Responsibilities

Develops and updates Study Supply Plans in close communication with CSO project Management LeadResponsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs.Manages the packaging Batch Record review and approval process with Quality Assurance and other CSO personnel.Works closely with Quality Assurance to obtain temperature excursion disposition to update impacted inventory in IRT and other related systems.Coordinates authorized destruction of investigational products with approved vendors and obtains required documentation.Vendor Management –supports Person in Plant (PIP) activities when packaging operations for DSI are in-process. Supports investigational product distribution activities at the vendor, including generation of drug orders, review of shipping documentation and obtaining approval to shipAssists in the creation of SOP’s and work instructions specific to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education Qualifications (from an accredited college or university)

Bachelor's Degree requiredExtensive relevant experience will be considered in lieu of an advanced degree. preferredPharmD or related field preferredMaster's Degree preferred

Experience Qualifications

7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferredOncology experience preferredCreation of Supply Planning tools preferred

Travel

Ability to travel up to 10% Overnight / single-day travel will be required to go to outsourcing vendors from time to time infrequently.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

  • Project Lead, Program Management, CSP&O

    2 months ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Clinical Safety Scientist Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States The Fountain Group Full time

    Job Title: Associate Director - Clinical Safety ScientistJob Schedule: The ideal candidate will be local and able to work in the office 1-2 days a week. Global Travel ~ 20% of Time. Pay rate: $100/Hr.Responsibilities & Job DetailsThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs,...

  • Clinical Safety Scientist Lead

    5 days ago

    Basking Ridge, New Jersey, United States Hire Talent Full time

    Job Title:Associate Director Clinical Safety ScientistJob Summary:We are seeking an experienced Associate Director Clinical Safety Scientist to lead our clinical safety and risk management efforts. The successful candidate will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to...

  • Clinical Safety Scientist Lead

    5 days ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Associate Director, Clinical Safety ScientistAbout Daiichi Sankyo, Inc.Daiichi Sankyo, Inc. is a leading pharmaceutical company dedicated to creating innovative therapies to improve standards of care and address unmet medical needs globally. With a rich legacy of innovation and a robust pipeline of promising new medicines, we are committed to...

  • Clinical Study Lead Manager

    3 weeks ago

    Basking Ridge, New Jersey, United States Proclinical Staffing Full time

    Senior Manager, Clinical Study LeadProclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations.Key Responsibilities:Develop and manage study-specific documentation, ensuring compliance with regulatory requirements.Supervise the setup and maintenance of study systems, including CTMS and TMF.Ensure compliance...

  • Clinical Safety Scientist Lead

    3 weeks ago

    Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Clinical Safety Scientist Lead to join our team at Planet Pharma. As a key member of our safety team, you will be responsible for proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.Key...

  • Associate Director Clinical Safety Scientist Lead

    5 days ago

    Basking Ridge, New Jersey, United States The Fountain Group Full time

    {"title": "Clinical Safety Scientist Associate Director", "subtitle": "Join The Fountain Group", "content": "Clinical Safety Scientist Associate DirectorWe are seeking a highly skilled Clinical Safety Scientist Associate Director to join our team at The Fountain Group. As a key member of our safety team, you will be responsible for proactively performing...

  • CSPV Project Manager Lead

    5 days ago

    Basking Ridge, New Jersey, United States HireTalent - Diversity Staffing & Recruiting Firm Full time

    Job Title: CSPV Project ManagerLocation: Remote opportunityDuration: 6+ monthsPay: $65-$70/hourJob Description:Main Responsibilities:Lead cross-functional teams in project management and execution for key initiatives across CSPVSupport the Management Office and Business Excellence lead in implementing PMO structure within CSPVCollaborate with CSPV leadership...

  • Clinical Safety Lead

    5 days ago

    Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job SummaryWe are seeking a highly skilled Clinical Safety Scientist to lead our safety surveillance and risk management efforts for a large, late-stage program or multiple early-stage programs. The ideal candidate will have a strong background in clinical development and safety risk management, with experience in proactively identifying and mitigating...

  • Technical Project Lead

    5 days ago

    Basking Ridge, New Jersey, United States KellyMitchell Group Full time

    Job Summary:We are seeking a highly skilled Technical Program Manager to join our team at KellyMitchell Group. This position offers a unique opportunity to work with a dynamic team and contribute to the success of our clients.Key Responsibilities:Support and lead digital initiatives from start to finish, including business case development, cost-benefit...

  • Executive Director, Head of ADC/Bio II, Project Lead

    2 months ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Director, Clinical Science

    4 months ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Director, Clinical Science

    3 months ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Sr. Manager, Clinical Study Lead

    3 weeks ago

    Basking Ridge, United States Proclinical Staffing Full time

    Senior Manager of Clinical Study Lead - Contract - Basking Ridge NJProclinical is seeking a Senior Manager, Clinical Study Lead to oversee and manage clinical study operations. Primary Responsibilities:This role focuses on developing study-specific documentation, ensuring compliance, managing budgets and timelines, and leading risk assessments. The...

  • Clinical Safety Scientist Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States Planet Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistThis role serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage programs, proactively performing safety surveillance and risk management in partnership with cross-functional teams to support the benefit-risk profile throughout the product lifecycle.The...

  • Clinical Safety Scientist Lead

    5 days ago

    Basking Ridge, New Jersey, United States Daiichi Sankyo, Inc. Full time

    Job Title: Clinical Safety Scientist LeadJob Summary:Daiichi Sankyo, Inc. is seeking a highly skilled Clinical Safety Scientist Lead to join our team. As a Clinical Safety Scientist Lead, you will be responsible for proactively performing safety surveillance and risk management in partnership with Product Safety Leads, Clinical Safety Physicians, and...

  • Manager, Quantitative Clinical Pharmacology

    1 month ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Senior Manager, Pharmacy Support Services Lead

    2 days ago

    Basking Ridge, New Jersey, United States BioSpace, Inc. Full time

    Job SummaryThe Senior Manager, Pharmacy Support Services Lead is responsible for driving activities related to Investigational Product used in the conduct of clinical research projects to ensure consistent deliverable of program objectives across our portfolio.This role partners with Formulation Development Group (FDG), as a SME in investigational product...

  • Senior, Clinical Study Manager

    1 month ago

    Basking Ridge, United States Daiichi Sankyo Full time

    Join a Legacy of Innovation 110 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 our world-class science and technology. With more than 120 years of scientific expertise and a...

  • Clinical Safety Scientist Lead

    4 weeks ago

    Basking Ridge, New Jersey, United States Planet-Pharma Full time

    Job Title: Associate Director Clinical Safety ScientistPlanet-Pharma is seeking an experienced Associate Director Clinical Safety Scientist to lead our safety surveillance and risk management efforts for late-stage programs and early-stage programs.Key Responsibilities:Proactively perform safety surveillance and risk management in partnership with...