Assoc Dir Clinical Supply Operations in Bernards, NJ at DSI

Date Posted: 2/6/2018

Job Snapshot

Job Description

About Daiichi Sankyo Cancer Enterprise

The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary

Working across the Global organization both within and across functions this position works primarily in a matrix environment and is capable of identifying transformational approaches and solutions. Develops Global relationships with cross functional teams to gain support and facilitate collaboration. This position works at both the project and compound level.

In-depth knowledge of cGMPs and GCPs in oncology and possesses significant knowledge of supply planning, comparator sourcing, global distribution, blinding approaches and technologies to support various clinical trial designs (dose escalation, titration, randomized, double-blind, double-dummy, placebo-controlled, cross-over, etc.).

Demonstrated experience to manage study needs and possesses the skills and ability to support large phase III Oncology programs. Such characteristics include the ability to evaluate, at times, limited information, to create supply agreements with internal partners, packaging designs and drug supply forecast. Extensive experience 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 Interactive Response Technology (IRT) system design for control of drug dispensing and inventory management, with a focus on Oncology projects. 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. Looks for emerging trends, technologies, and best practices.

High level of understanding of Global Pharmaceutical Development, Quality Assurance, and Regulatory (domestic and international).

Subject Matter Expert (SME) knowledge of clinical supply planning, manufacturing, packaging, and labeling as well as overall study management.

Direct supportive staff as required and works with a minimal level of supervision.

Responsibilities
  • 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 supply agreement ; based on a comprehensive 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.
  • Employee is wholly capable 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 collaboration 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. Work to be shared with CSO Supply Planning & Logistics (SP&L)
  • 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 Company or Organizational Work to be shared with CSO Supply Planning & Logistics (SP&L) Requirements that comply with all regulatory requirements.

In collaboration with clinical, biostats and data management etc., the IRT RFQ is drafted and the User requirement Specifications are prepared. CSO 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

Education
  • BS in Pharmacy or related field—MS or PharmD a plus
Experience
  • Minimum 7 - 10 years of related experience.
  • Experience in Project Management, Oncology Clinical Supply Management, and/or Pharmaceutical Development required.
  • Highly experienced managing third-party contract clinical supply operations and highly skilled and has excellent capabilities in the processes for assimilation and destruction of returned drug supply from sites to depots.
  • Global experience required, experience leading teams preferred.
  • Comparator product sourcing.
  • Experience collaborating with other sponsor companies on combination studies a plus.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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.