Manager, Project Lead, Program Management (Clinical Trial Supply)

At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

Job 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 Lead Responsible 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 ship Assists 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 documents Supports the CSO Project Mgmt Lead in executing additional operational and logistical duties as discussed and agreed to by management

Qualifications

Education Qualifications
Bachelor's Degree Bachelor's degree in Science or related field. Extensive experience will be considered in lieu of an advanced degree required

Experience Qualifications
7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. preferred
Oncology experience preferred
Creation of Supply Planning tools preferred

Travel Requirements
Ability to travel up to 10% of the time. 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.

Salary Range:

USD$116,400.00 - USD$174,600.00