Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com .
This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply.
Purpose and Scope:
Provide global development science and strategic expertise to projects within a specific TA
Provide regulatory expertise for clinical pharmacology registration within a specific TA
Have thorough understanding of exploratory development, clinical methodologies, POC, and clinical endpoints within a specific TA
Provide creative clinical pharmacology input for profiling of Astellas compounds to enable successful commercial differentiation
As a GCPL for phase 3 programs, will ensure efficient delivery of clinical studies within a TA, under the responsibility of CPED for registration
Essential Job Responsibilities:
Provides disease area expertise and opportunities for CPED-science contributions to Core Team
Oversees interpretation of complex data, provides leadership to Core Team in model-based drug development, introduces “state-of-art” translation medicine strategies, platforms and methodologies to Core Team
Defines and maintains a leading overall exploratory development and clinical pharmacology strategy that will ensure the success of Astellas. Where appropriate, prioritize studies within CPED.
Contributes to the definition of world class, leading exploratory development, clinical pharmacology that will ensure success of Astellas projects.
Responsible for providing scientific oversight for preparation of various sections of regulatory documents, such as IB, IMPD and CTD.
Provides appropriate clinical pharmacology scientific input on licensing opportunities.
Contributes to the preparation of the capacity and budgetary information related to approved development projects, maintenance and marketing support projects, infrastructural projects and/or departmental activities
Contributes to the definition, implementation and maintenance of new multidisciplinary ways of working in order to improve the efficiency and effectiveness of CPED
Displays leadership attributes that lead to the improvement of CPED processes and level of science
Be the Global Clinical Pharmacology Lead for in-house discovered or in-licensed compounds.
This requires leading a cross functional team of 15 – 25 experts in toxicology, pharmacology, translation, Clinical Pharmacology Operations. Responsible for delivery of Exploratory Development strategies to Proof of Concept or Clinical Pharmacology strategies through registration.
Be involved in the design, analysis, and reporting at least 3 to 10 clinical studies per year
As a GCPL, provide the scientific lead for a cross-functional team of 15 - 25 people
Supervise 1-3 junior CPED scientists.
Responsibilities may directly impact on strategy and efficiency of clinical development of compounds.
Has responsibilities for contributing to the overall annual budgeting and assessment of resources for assigned projects for executing clinical pharmacology strategy from FIM to registration
Has responsibilities that directly impacts on strategy and efficiency of clinical development of compounds, especially in the early and late phases.
Reports to Senior Director or Executive Director, CPED Science
May have direct reporting CPED scientists who are responsible for providing contributions to individual projects
May have functional management of scientists
The total budget of the clinical pharmacology science section will be around 4M $USD, annually
MD/ PhD /PharmD
Requires at least 7 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a good understanding of Drug Discovery and Development.
Thorough understanding of clinical pharmacology discipline and how it is applied throughout all phases of drug development
Thorough understanding of regulatory strategies and guidelines
Extensive experience in regulatory filings, eg., IND, IMPD, NDA, etc.
Extensive experience in regulatory interactions with regulatory authorities worldwide
Strong leadership skills
- Prior experience with Oncology or Cell Therapies/Biologics
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
Category Early Development
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans