Senior Program Lead/Director, Clinical Supply Operations

Location
Basking Ridge, New Jersey, United States
Posted
Sep 16, 2020
Ref
10198BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

This position is responsible for enabling the on-time delivery of clinical supplies for programs with the greatest financial, technical, and geographic complexity and represents the highest priority across the DSI portfolio. Works closely with multiple SP&L support resources to ensure clinical supplies for assigned programs are manufactured, packaged, labeled and distributed on time to support Phase 2 - 4 trials and required stability studies, with no supervision. This includes but is not limited to assuring availability of comparator products, investigational drug product, interpreting clinical protocols, development of complex Supply Plan Agreements (SPA), and generation and maintenance of numerous study-level budgets.

This position is also responsible for significant budget development and control given the comparator sourcing and GMP processing costs associated with later stage program support.

Responsibilities:

Understands the overall Compound Development Plan (CDP) and critical longer term deliverables for CSO. Makes recommendations for strategic sourcing of comparators, and placement of work based on CDP requirements and in alignment with CSO mgmt. strategy. Manages the planning and execution of CSO work streams in close collaboration with SP&L support.

Actively participates in and influences the design of overall clinical plans and study protocols by ensuring CSO strategies are incorporated into the final output. Drives the comparator sourcing strategies, including site sourcing and optimal method of GMP processing. Translates protocol requirements and study milestones into an actionable Supply Plan Agreement

Collaborate with clinical teams on forecasting and delivering supply assessments to the appropriate planning functions within Global-PT. Develop both detailed program and study-level budgets frequently involving high value comparator products.

Recommend matching placebo and comparator drug sources. Develop appropriate blinding strategies and coordinate team efforts for analytical method development, stability studies and regulatory CMC filing (domestic and international).

Identify emerging trends, technologies, and best practices and work with CSO management to implement change as appropriate.

Mentors junior staff on best practices and approaches for planning CTM delivery and relationship building with Clinical colleagues

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

Education/Experience:

BS/BA required. Degree in pharmacy or related field preferred. MS or PharmD highly beneficial.

Minimum 11 years of related experience, including Project Management, Clinical Supply Management, and/or Pharmaceutical Development. Oncology experience is preferred. Creation of Supply Planning tools is preferred.

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.

Job Title
Senior Program Lead/Director, Clinical Supply Operations

City
Basking Ridge

Functional Area
Pharma Technology

State
New Jersey