Description
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 .
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:
The Executive Director, Medical Specialties Science & Operations provides overall global vision and direction for science within CPED from P0 to PMC
Build global CPED-Science capabilities across all Medical & Development TA's
Provide strategies for interaction with regulatory authorities related to CPED-Science issues and registration
Leadership position with direct reports
Essential Job Responsibilities:
To define, develop and lead the establishment of global CPED-science standards that upon implementation guarantee the generation and availability of appropriate CPED[1]science contributions across all Astellas' TAs in all phases of development and at registration.
Responsible for interfacing and collaborating with TA Heads and key APGD functions (ie GDPL, Medical Science, Data Science et al) to ensure integration of CPED --science into strategic plans
Be the key person to define and maintain a leading overall CPED-science strategy across all TAs, including the development and implementation of 3-5 year CPED-science specific mission, that will ensure Astellas' success
Responsible for establishment and implementation of a global CPED-science curriculum that ensures:
continuous development of all staff in the global CPED-science department
awareness and mastering of the latest techniques, applications and regulatory guidance in the area of CPED-science.
Develop and implement processes for growth and optimization of CPED science processes
Responsible for optimal allocation and management (EU and US) of expertise and resources
Foster partnership with Translational Science to ensure CPED science strategies are incorporated in clinical plans for the purpose of early decision making
Foster partnership with CPED PK/MS and operations to ensure delivery of timely results
Be the Astellas CPED-science representative to organizations outside the company, e.g., AAPS, ACCP, ASCPT, etc.
Mentor/coach lower level CPED-science scientists
Quantitative Dimensions:
Has responsibilities for the overall annual budgeting and assessment of resources for executing clinical pharmacology strategy from FIM to registration across all TAs
Responsible for allocating GCPL/CPED scientists resources to Core/Extended Teams to meet the needs of the TA timelines and requirements from FS stage through phase 4
Organizational Context:
Reports to Global Vice President, CPED
May have direct reporting CPED scientists who are responsible for providing contributions to individual TA's or projects
May have functional management of senior scientists and scientists
Staff from the section will work on 15 - 30 projects from P0 through registration and during commercialization.
Qualifications:
Required
MD/ PhD /PharmD is preferred
Requires 10-12 years post-graduate experience, in pharmaceutical industry, preferably from another (major) Pharma Company with a thorough understanding of Drug Discovery and Development.
Can integrate knowledge across all CPED functions
Thorough understanding of clinical pharmacology discipline and how it is applied throughout all phases of drug development
Thorough understanding and demonstrable experience with regulatory strategies and guidelines, and submissions
Personnel management experienced required
International recognition as expert
Strong leadership skills
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
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 Clinical Development
Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans
