Senior Director CMC Management and Operations in Bernards, NJ at DSI

Date Posted: 1/27/2018

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo, Inc. is the U.S. subsidiary of Daiichi Sankyo, Co., Ltd. The Company currently markets therapies in hypertension, dyslipidemia, diabetes, acute coronary syndrome, thrombotic disorders, stroke risk reduction, opioid-induced constipation, IV iron therapy and metastatic melanoma.

Job Summary

This position serves 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 in several therapeutic areas. The individual occupying this position defines the organizational strategy and plan for the CMC Management & Operations function, and ensures 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, the Senior Director collaborates cross-functionally and cross-regionally to identify, recommend and lead the implementation of alternative pharmaceutical sciences strategies. This position will require minimal supervision.

Responsibilities

1. 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 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). Apply sound scientific judgment to address development challenges and delays. Escalate significant matters accordingly.
2. 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 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 development projects. Recommend and implement strategies for project accelerations without risk to quality.
3. Develop and oversee the CMC Management & Operations organizational strategy and plan; be responsible for growing and shaping the Global CMC Management organization in collaboration with other functional leaders globally; represent and promote awareness of the CMC Management & Operations function to external functions and to senior management, both regionally and globally. Prepare and monitor development plans for staff members.
4. Research, advise and exchange technical information and ‘best practices’ for CMC development within the Global Pharmaceutical Technology Unit; identify and drive improvements in the global strategy of the Unit; collaborate across strategic interfaces with other functions (e.g. CSO, QA, RACMC, TMCP, Clinical Development, SC etc.) and regions (e.g. DSD, DSE, DST etc.) to refine existing strategies and identify and implement new strategies as required.
5. 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.
6. Represent the Global Pharmaceutical Technology Unit on external industry, academic and regulatory groups.
7. Represent the Global Pharmaceutical Technology Unit on Alliance/Co-development strategy teams for both early and late phase projects.
8. Strategic and operational leadership and management of global and regional CMC development teams (CMC sub-teams) 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.
9. 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

Education
  • PhD in chemistry, biochemistry, or other discipline within pharmaceutical/biotechnology sciences, or a corresponding Masters/Bachelor’s degree
Experience

The following is required:
  • At least 12 years’ experience ( 10 years’ experience with Ph.D.) in the pharmaceutical/biotechnology industry working in the drug development environment.
  • Experience leading, managing and mentoring a function comprised of technical leaders and technical project managers.
  • Experience in process, product and analytical development activities and a knowledge of global CMC regulatory requirements.
  • At least 5 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.
  • Experience in bringing development candidates through late stage clinical development, filing, approval, and commercialization. Experience in filing a Biologics License Application (BLA) preferred.
  • Experience working within a global matrix organization.
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.