Sr. Project Lead/Manager, Clinical Supply Operations
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 presence in more than 20 countries, Daiichi Sankyo and its 15,000 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.
This position will work at the Project level while contributing to the Compound level. Working across the Global organization both within and across functions this position works primarily in a Transactional environment and may contribute to Transformational approaches and solutions. Develops Global relationships with cross functional teams to gain support and facilitate collaboration.
Good knowledge of cGMPs and GCPs across multiple therapeutic areas and possesses general knowledge of blinding approaches and technologies to support various clinical trial designs (randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.).
Experienced to manage study needs and possesses the skills and ability to potentially support large phase III Programs. Such characteristics include the ability to evaluate, at times, limited information, to create packaging designs and accurate drug supply forecast. Experienced in managing third-party contract clinical supply operations. Support the CSO strategy on specific Programs and Projects to support corporate goals and objectives.
Employee should have comprehensive knowledge of IRT design for control of drug dispensing and inventory management. Knowledge of Import/export regulations, including pro-forma invoice generation, import regulations at a Global level, regulations for IMP QP requirements.
Align with other departments in meeting Project related goals but can challenge existing processes to help drive efficiency and solutions. May contribute to identifying emerging trends, technologies, and best practices.
High level of understanding of Global Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).
Demonstrated knowledge of clinical supply planning, manufacturing, packaging, and labeling as well as overall study management. May require support on critical issues during development of solutions and during the course of Project execution.
- Participate in study team meeting, align with study details and collaborate in meeting study objective, Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs.
- Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient friendly designs and support of simplified site dispensing approaches.
- Create drug supply forecast for packaging and labeling operations. Support patient study needs that consider enrollment rates, country logistics for shipping and importation, drug expiry, inventory re-supply strategy and the appropriate level of inventory per region.
- On-going monitoring of recruitment, drop-out rates and actual supply needs, critical to managing the study needs. Ensure continuous re-assessment of Project needs as recruitment and the study progresses
- Sourcing of comparators and matching placebo as required on a Project by Project basis.
- Drive label generation and approvals, including obtaining translations for all participating countries and the associated regulatory statements. Obtaining cross functional sign off on the labels.
- ability to provide budget management for Projects - initial budgets are prepared against available information and a set of assumptions and become more stringent as the study start approaches. Spend against PO's are monitored and extensions justified. Costs saving strategies are employed when appropriate. Invoices are reviewed and approved against targeted budget plans.
- Generate RFPs for Vendor Proposals - Breakdown Protocols into component parts to support the supply strategy and communicate the study needs to obtain vendor based budgeting or internal support
- Vendor selection to support studies is evaluated according to capability and fit with outsourcing Strategy and selection of contractors is made in agreement with line management. Contracts are negotiated with the most favorable terms for DS in collaboration with Outsourcing
- Vendor Management - Proactively review with the Vendor the study status on a regular basis. Review the initial supply needs for start-up, ongoing resupply strategy and amendments and closeout requirements. Address budgets and invoicing considerations with the vendor along with the study management details and capture any impacts.
- Support of regulatory filings including IND submission information, regulatory audits and information to support regulatory audits. Provide regular updates to the TMF as per departmental and Corporate requirements that comply with all regulatory requirements.
- ICSO supports the generation of the CSO relevant section of User specifications for IRT and User Acceptance Testing, taking responsibility for the relevant portion of the IRT process covering essentially dispensing and triggers for re-supply and controls to ensure non dispensing of expiring or expired product. The requirements also cover all relevant report functionality.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
- BS in Pharmacy or related field—MS or PharmD a plus
- Minimum 5 years of related experience
- Experience in Project Management, Clinical Supply Management, and/or Pharmaceutical Development required
- Experience and skill in the processes for assimilation and destruction or returned drug supply as well as experience managing third-party contract clinical supply operations required
- Global experience required (member of a team).
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.