Associate Director, Program Lead – Clinical Site Management, CSP&O

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 our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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:

The qualified candidate will provide knowledge-based coordination, authoring, and management of Dose Preparation Instructions in support of clinical studies being conducted globally by Daiichi Sankyo. The candidate will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders. Collaboration with external stakeholders (e.g., research pharmacists, clinical study partner management) may also be required. Additionally, the candidate will also support the CSO Supply Planning & Logistics (SP&L) function with assigned tasks related to steady supply of Clinical Trial Materials (CTM).

Responsibilities

• Lead the authoring, revising, and managing the day-to-day activities associated with the Dose Preparation Instructions Pharmacy Manual in support of the DSI portfolio. Provide strategic leadership related to HCP focused training materials; Has a focus on strategic and operational excellence; Provide input in Patient Focused Initiatives in close collaboration with RD colleagues.

• Drive discussions with Clinical Operations and the scientific SMEs, prepare and Coordinate responses to queries from the clinical study sites on the Dose Preparation Instructions. Seek input from other global functions as needed; proactively identify and resolve any technical, communication, and administrative issues. Help to improve and ensure consistency, where applicable, among various types of dose-prep instructions (e.g., frozen liquid, lyophilizate, intermediate dilution requirement).

• Create and maintain a database of commonly-used materials of contact construction and queries from the clinical sites. Use such databases to help streamline and improve consistency of DPI documents between projects and to identify potential “problem” areas where queries/issues are frequent.

• Support SP&L tasks related to steady mgmt. of CTM supply to clinical sites and resolution of related queries. Actively participate/contribute to discussions in applicable working teams, technical teams, project teams, etc.

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 Degree in pharmacy, biochemistry, (bio) chemical engineering, chemistry or other discipline within the pharmaceutical/biotechnology sciences or related field required

• Master's Degree preferred or PharmD preferred

Experience Qualifications

• 7 or More Years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development or technical writing required

• 1 or More Years experience in the development of parenterally-delivered oncology drugs preferred

• 1 or More Years assessing compatibility of supplies commonly used in compounding preferred

• Creation of Supply Planning tools preferred

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

• Communications (electronic and teleconference/videoconferencing across global time zones, global and domestic travel required.

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.