Astellas Pharma Associate Director, Clinical Program Management in Northbrook, Illinois
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 & Scope:
Accountable for the execution of assigned studies or programs. Responsible for leading cross functional study teams to ensure operational excellence/quality in the design, execution and completion of studies/projects. As requested, may represent CS as a core team member under the leadership of Director/Sr. Director, Clinical Program Management.
Oversees and manages clinical study associates (CSA), clinical study managers (CSM) and/or Sr. Clinical Study Manager (Sr CSM) which are assigned to studies within Clinical Science (CS).
Participates in global/local drug-product and non-drug product initiatives as a Clinical Science representative.
Represents CS in due diligence activities for compounds/programs which may be in-licensed or acquired. Expectations may include the working with the DD team to design clinical development program including timelines and budgets to support registration.
Essential Job Responsibilities:
Actively participate and engage in development and execution of Clinical Development Plans for compounds assigned including development of the study timelines, budgets and resource needs.
Develop and implement plans to achieve project and study team objectives
Provide oversight of budget and resources, and contribute to the management of the entire Global Clinical Science budget
People Management and Development
May be responsible for managing up to10 individuals directly
Responsible for effective delegation to staff as appropriate to meet project/study goals
Responsible for development / career management and retention of staff
Provide oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards
Inspire individuals while holding them accountable for project and study delivery, and to provide expert clinical science input into development programs
Strategic thinker and problem solver, who recognizes, anticipates and solves problems helps individuals to develop problem solving skills. Must be able to delve into high degree of detail when necessary
Facilitate problem solving and conflict resolution with internal and external stakeholders to proactively reduce issues /remove roadblocks to keep teams on target to meet key deliverables
Contribute to development and implementation of best in class standards, processes and SOPs in clinical science
Responsible for execution of company or departmental wide initiatives within their studies and direct staff's studies
Participates in strategic improvement projects as requested
Responsible for overseeing the preparation and management of budgets, resources and timelines for assigned studies/projects. Budget responsibility could be greater than 300 million US dollars.
Reports to Director, Clinical Program Management or above. May be responsible to manage up to 10 direct reports. May be requested to participate in core team, but is responsible to work with Manager to oversee/lead studies/projects as assigned working with extended study team members.
BA/BS degree with at least 8 years clinical trial management experience; advanced degree
(MS, PhD, PharmD) with at least 6 years clinical trial management experience
Must have strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
Must have a strong knowledge of protocol and clinical drug development processes, clinical study design, study planning and management.
Must have experience working across multiple phases of development.
Must have proven leadership skills and effective written and verbal communication skills
Fluent in English
Moderate (up to 25%) travel required, depending upon assigned program/studies and phase.
Minimum of 1 - 2 years direct people management experience
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