Senior Director, CMC Management & Operations in Basking Ridge, NJ at DSI

Date Posted: 7/16/2021

Job Snapshot

Job Description

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.

Job Summary:

This position will serve as the head of the CMC Management & Operations function, providing leadership, performance management and mentorship for a group of technical leaders and technical project managers working across a portfolio of drug development projects. This position will define the organizational strategy and plan for the CMC Management & Operations function, and ensure that it is integrated with those of other functions across the global organizational matrix. As a functional and technical leader within the Global Pharmaceutical Technology Unit, this position will collaborate cross-functionally and cross-regionally to identify, recommend and lead the implementation of alternative pharmaceutical sciences strategies. This position will require minimal supervision.

Responsibilities:

Provide leadership, performance management and mentorship for a group of technical leaders and technical project managers whose primary responsibilities are: (a) to develop, implement and oversee global and regional CMC development strategies and operational plans that are integrated with the strategies and plans of the R&D, Commercial and Supply Chain (SC) functions represented on drug development project teams, and (b) to provide technical and business leadership and technical project management of services performed by vendors (CXOs).

Oversee CMC development strategies and operational plans across a portfolio of projects and ensure that they are aligned with the strategic and operational objectives of the Global Pharmaceutical Technology (G-PT) Unit, and those of the R&D, Commercial and Supply Chain functions; make decisions on prioritization, budgets, and resource allocation for the CMC Management & Operations function across a portfolio of projects.

Develop and own the CMC Management & Operations organizational strategy and plan; be responsible for growing and shaping the Global CMC Management organization in collaboration with other global functional leaders; represent and promote awareness of the CMC Management & Operations function to external functions and to senior management, both regionally and globally.

Research, advise and exchange technical information and ‘best practices’ for CMC development within the Global Pharmaceutical Technology (G-PT) Unit; identify and drive improvements in the global strategy of the Unit; collaborate across strategic interfaces with other functions (e.g. CSO, QA, RACMC, Clinical Pharmacology, Clinical Development, SC, etc.) and regions (e.g. Daiichi Sankyo Europe, Daiichi Sankyo Japan etc.) to refine existing strategies and identify and implement new strategies as required.

Represent the Global Pharmaceutical Technology Unit on due diligence teams, coordinating the input of global technical and functional experts as required; make recommendations to Business Development and senior management within the Global Pharmaceutical Technology Unit.

Represent the Global Pharmaceutical Technology Unit on external industry, academic and regulatory groups.

Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development strategy teams for both early and late phase projects.

Provide strategic and operational leadership and management of global and regional CMC development teams (CMC subteams) for multiple drug development candidates across all phases of development; lead the establishment of integrated global and regional CMC development strategies and operational plans and oversee their execution.

Represent CMC development teams on global and regional cross-functional drug development project teams with both a strategic and operational focus, and to global and regional senior management within the Global Pharmaceutical Technology Unit; ensure the establishment of drug development project strategies and operational plans that optimally integrate the CMC development strategies and operational plans with those of other functions in order to expedite successful product development, regulatory approvals and commercialization; recommend improvements in drug development project strategies and plans.

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

Education/Experience:
  • PhD in chemistry, biochemistry, or other discipline within pharmaceutical/biotechnology sciences preferred
  • Master's Degree with 15 years industry experience preferred
  • Bachelor's Degree with 15 years industry experience preferred
  • 10 or More Years experience leading, managing and mentoring a function comprised of technical leaders and technical project managers required
  • 4 or More Years experience leading CMC development teams for drug development candidates, and representing those teams on cross-functional drug development project teams in a global setting, or equivalent required
  • At least 15 years experience in process, product and analytical development activities and a knowledge of global CMC regulatory requirements preferred
  • 4 or More Years experience working within a global matrix organization preferred
  • At least 15 years of experience in the pharmaceutical/biotechnology industry working in the drug development environment 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.