"Alerted.org

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 clinical pharmacology scientific support to individual projects/studies within a therapeutic area.

Responsibilities and Accountabilities:

+ Providing scientific support on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing

+ Participating in cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals.

+ Providing clinical pharmacology input to clinical trials (including study design, interpretation and communication of results)

+ Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions

+ Participating in development of high-quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans

+ Presentation of clinical pharmacology aspects of the global clinical development program at internal or external meetings.

Quantitative Dimensions:

+ Be involved in the design of at least 2-3 Early Development or Clinical Pharmacology strategies per year.

+ Contribute to on an average 1-2 Translational Science Plans on novel projects.

+ Be involved in the design of at least 2-3 study protocols per year

+ Provide scientific contributions to 1-2 Safe First Dosing documents for compounds proposed to be entered first to humans.

+ Contribute to on average at least 1-2 IB/IMPD/IND regulatory documentations.

Qualifications:

Required

+ PhD or PharmD with fellowship in clinical pharmacology or MS with at least 7 years of industry experience

+ 2-4 years post-PhD with thesis relevant to Clinical Pharmacology; or PharmD with clinical pharmacology fellowship and at least 2 years industry experience; or MS with at least 7 years of industry experience within Clinical Pharmacology

+ Knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidances

+ Working knowledge of biomarkers, bioanalytical methods, immunogenicity

+ Excellent written and oral communication skills and ability to convey complex technical information clearly

+ Knowledge of clinical pharmacology in drug development, pharmacokinetic/pharmacodynamic relationships with a strong scientific and strategic mindset

+ Knowledge of integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan

+ Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics

+ Curiosity and drive to ask questions, learn and keep abreast of literature.

+ Confidence and ability to present to and influence senior leaders.

+ Ability to critically analyze problems and provide creative/innovative solutions.

Salary Range

$125K – $170K (NOTE: Final salary could be more or less, based on experience)

Benefits:

+ 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

\#LI-SS

Category Clinical Pharmacology

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans