Director - Global Clinical Pharmacology and Exploratory Development Science - Oncology - Astellas - Northbrook

Job description
Essential Job Responsibilities:
1. Provide Clinical Pharmacology (CP) & Exploratory Development (ED) expert input to the development strategy of Astellas compounds with a global company perspective.
2. Provide scientific leadership in design of clinical pharmacology studies and development of CSR
3. 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 leading to successful regulatory filings
4. Provide clinical, (medical) scientific input to Translational Science Plans
5. Be actively involved in Translational Science discussions
6. Represent GCPED on Core Project Teams.
7. Knowledgeable of certain Disease Areas in order to ensure availability of state-of-the art knowledge and experience in Translational Science for practical application in clinical development.
8. Provide clinical input to Safe First Dose document to guarantee the safety of first dosing to man.

9. Be the Global Clinical Pharmacology science Lead (with supervision) for in-house discovered or in- licensed compounds. This requires evaluating the input from a cross functional team of 15 -- 25 experts in toxicology, pharmacology, ADME, PK, MS, CP Ops.
10. When required represent GCPED in Due Diligence activities
11. Maintain a current awareness of trends and developments in various expert fields of the department.
12. Act in a global perspective with authorized responsibility in the fields of GCPED disciplines.
13. Publishes study results as appropriate.
14. Responsible for having significant scientific input into the various sections of regulatory documents, such as IB, IMPD and CTD.
15. May lead various working groups or initiatives to improve internal processes or best practices with the goal of improving GCPED expertise and efficiencies

* Design at least 2-3 Exploratory Development or Clinical Pharmacology strategies per year.
* Contribute to on average 3-5 Translational Science Plans on projects.
* Provide (medical)/scientific contributions to 1-2 Safe First Dosing documents for compounds proposed to be entered first to humans.
* Contribute to on average at least 2-4 IB/IMPD/IND regulatory documentations.
* 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.

Organizational Context:

* Reports to Senior Director or Executive Director, GCPED Science, Oncology

Required
* Preferred MD/ PhD /PharmD or MS with exceptional experience
* Requires minimum 5 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a good understanding of Drug Discovery and Development.
* Experiece in drug development of oncology drugs with primary focus on clinical pharmacology
* Expert knowledge of disease biology and relevant clinical disease knowledge required to design early development strategies up to and including PoC.
* Experience interacting with regulatory authorities and preparation of IND, IMPD, NDA, etc
* Expert technical knowledge of Clinical Pharmacology
* Operate with minimum of supervision within a project.
* Up to date with latest ICH-GCP guidelines and other relevant regulations.
* Highly developed sense for ethical conduct of Clinical Development
Preferred

* Knowledge of translational research related to pharmacodynamics and predictive bio-markers as well as companion diagnostics is preferable

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