An Astellas career offers a totally different way to work and live.

Astellas is the bright spot in the pharmaceutical industry – not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine. We offer a different kind of work culture. A high standard of ethics is mandatory. Quality is our pledge. Diversity is valued. Individual initiative is rewarded. Astellas offers an environment where our employees can make a real difference. Come, shine with us!

Astellas is announcing an Associate Director, CPED Science, Oncology opportunity in our Deerfield, IL location.

Provide Exploratory Medicine (EM) & Clinical Pharmacology (CP) expert input to the development strategy of Astellas compounds with a global company perspective.
Design and ensure delivery (through scientists and CP Ops) to core teams of creative, effective early clinical development strategies up to and including Proof of Concept and later on Clinical Pharmacology strategies
Provide clinical, (medical) scientific input to Translational Science Plans
Be actively involved in Translational Science discussions in particular Disease Areas in order to ensure availability of state-of-the art knowledge and experience in Translational Science for practical application in clinical development.
Provide clinical input to Exploratory Development Assessments to guarantee the safety of first dosing to man.
Be the Global Clinical Pharmacology Lead for novel in-house discovered or in-licensed compounds. This requires leading a cross functional team of 15 – 25 experts in toxicology, pharmacology, ADME, PK, MS, CP Ops.
When required represent GCPED in Due Diligence activities
Maintain a current awareness of trends and developments in various expert fields of the department.
Act in a global perspective with authorized responsibility in the fields of EM/CP disciplines.
Publishes study results as appropriate.

Quantitative Dimensions.

Design at least 2-3 Exploratory Development or Clinical Pharmacology strategies per year.
Contribute to on average 3-5 Translational Science Plans on novel projects.
Provide (medical)/scientific contributions to 1-2 Exploratory Development Assessments for compounds proposed to be entered first to humans.
Contribute to on average at least 2-4 IB/IMPD/IND regulatory documentations.
Be involved in on average 5 – 10 due diligence activities
As a GCPL, provide the (medical) scientific lead for a cross-functional team of 15 - 25 people (e.g. scientists from PK, Translational Science, Toxicologist) in the design and delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.
Supervise at least 1-3 junior CPED scientists on the delivery of strategies
Coach 1-2 new staff members on company and project team related procedures within APGD, US.
The position has no direct budget responsibility, however the plans based on contributions may require budgets of up to 30 M USD.
 

Position Requirements Minimum MS or equivalent qualification in a bio-medical/science field required. MD or PhD desired.
The Assistant/Associate Director role requires at least 5-7 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a general understanding of Drug Discovery and Development. In addition, the individual should have the following experiences.
Expert knowledge of disease biology and relevant clinical disease knowledge required to design early development strategies up to and including PoC.
Expert knowledge of Clinical Pharmacology
Knowledge and proven development expertise in at least 3 therapeutic areas.
Team player with strong written and communication skills to bring over and get acceptance for plans.
Strong, critical analytical mind
Operate with minimum of supervision.
Key organizer and planner who clearly sets priorities.
Up to date with latest ICH-GCP guidelines and other relevant regulations.
Highly developed sense for ethical conduct of Clinical Development
 

Grade Level 23 

To apply to this position please apply to www.us.astellas.com