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Astellas is announcing an Director/Senior Director, Global Development Project Lead, Oncology opportunity in Deerfield, IL

Responsible for providing strategic direction and leading the global drug development for assigned projects from pre-clinical GLP tox to commercialization.

Provides strategic direction and leadership of global development programs from P0 to NDA/MAA for assigned projects in accordance with the global oncology area strategy. Provides global development strategy and leadership for assigned projects from the perspectives of effective and efficient development.
(This will entail working closely with TAH and other colleagues to collaborate and ensure their buy-in and knowledge-sharing in establishing and implement the global development strategy for assigned projects.)

Ensures that the development team for assigned projects implement and adhere to key development milestones for assigned projects.

Accountable for aspects of pre-clinical, CMC, clinical plans and programs across all phases of development (from P0 through commercial approval) for assigned projects.

Chairs the global project team and reviews development plans for assigned projects at all milestones

Defines creative approaches for enhancing product value for assigned projects by promoting brand recognition and thorough product lifecycle management for assigned projects.

Contributes to appraisal of core team members for the conduct of all project-related activities.
 
 

Position Requirements
An MD, PhD or PharmD is preferable with a specialty in the assigned oncology area, or equivalent experience with global development required. Total leadership experience including line/project management. multidisciplinary program management experience, which includes leadership in more than one IND/IMPD, NDA/MAA, Advisory Committee or other PMDA/EMEA/FDA meetings.

Minimum of ten (10) years experience in drug development in pharmaceuticals, biopharmaceuticals, or biotechnology.

Demonstrated experience leading the development of at least one development candidate with adherence to quality, excellence and efficiency.

Demonstrated experience leading drug development projects and activities in a matrixed, global organization.

A broad understanding of how to communicate and work well with team members and relevant people as well as scientists and external decision-makers worldwide.

A thorough understanding of how to influence local and global regulatory, scientific and commercial environments.

Skill Set:
o Ability to assimilate data, recognize key variables and analyze complex situations. Make quality judgments.
o Has a realistic expectation of the business, one’s self and others.
o A style which builds alliances within the organization, locally/globally, and/or corporate collaborators.
o Does not confuse effort for results.
o Tenacity to weather short-term setbacks for long-term advantages.
o Broad understanding of the multidisciplinary functions contributing to effective and efficient drug development.

Solid understanding of CMC, pharmacology, toxicology, PK, clinical requirements to support major regulatory filings – IND/IMPD, NDA/MAA
.
Leads preparation of PMDA/EMEA/FDA milestone meetings, such as Pre-IND, End-of-Phase II, Pre-NDA, Advisory Committees, focusing on the key strategic issues.

Excellent understanding of the interdependencies of the various disciplines (CMC, Pharm/Tox, PK, Clinical, Regulatory, Marketing, Finance, etc) - what needs to be evaluated simultaneously vs. sequentially etc. from a strategic planning/risk management time/event/cost point locally and globally.

Understanding of how to educate/advise others on Regulatory Guidances/Internal SOPs/PM concepts.
 

Grade Level 25 

 

 

 
 

 

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