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:
This position will provide vision, leadership and strategic direction for the oversight and execution of post-POC clinical trials globally for Oncology (including Immuno-Oncology). This position may also have responsibility for digital and combination drug-device therapeutics. This may also include oversight and input on pre-Approval access studies and strategies, for relevant Therapeutic Areas.
In alignment with the overall mission of Medical and Development, this position will be responsible for the optimization of Clinical Operations departmental processes between the Primary Focus Areas and across regions.
This position is a member of the Clinical Operations Leadership Team and will provide input into departmental structure, budget and resourcing strategies, including development and implementation/oversight of processes and procedures focused on increased productivity and quality, as well as talent development.
Essential Job Responsibilities:
Leads the development and implementation of aligned Clinical Operations PFA strategies, standards, processes
Oversees the recruitment, development, and deployment of resources, ensuring “ready now” talent in support of the portfolio
Oversees operational activities to ensure regulatory compliance
Represents or delegates representation of Clinical Operations on the protocol approval committee (or equivalent) to ensure protocols accurately and effectively reflect the scientific hypothesis being tested
Develops and maintains strong collaborations across M&D and within the relevant PFA Leadership, to ensure consistent alignment of operational delivery to portfolio prioritization
Develops an environment that enables the Clinical team to operate optimally in a matrix environment
Lead and support as a Subject Matter expert, Divisional and cross-Divisional change and transformation improvement and develops a culture of continuous improvement to demonstrate improvements in speed, cost and quality, with a focus on Value for Astellas and external stakeholders
Clinical representative or leader on internal and external leadership/governance teams to oversee and ensure high quality delivery of all internally supported and outsourced clinical operations work
This position oversees and is accountable for the Clinical operational delivery budget, timelines and quality within the assigned portfolio. This includes planning and execution for all post-POC clinical trials, including pre-approval access.
Reports to the Senior Vice President, Clinical Operations and provides functional leadership and management globally of ≥6 direct reports with ~50 employees globally.
15+ years of pharmaceutical industry experience with at least 12 years of direct clinical trial management experience
Demonstrated experience managing Phase II through Phase IV studies globally (including pre-approval access) with minimum 5 years in leadership level role for global Phase II and III clinical program(s)
Demonstrated experience in leading a clinical team in the management and completion of multiple or complex clinical program(s) and participated in a regulatory submission(s) (preferably US, Japan and EU). Proven track record of successful studies (delivered on time, within budget, and with high quality).
Extensive expertise in developing operational strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operational, regulatory, quality and legal aspects)
Strong Therapeutic area knowledge and the ability to support the design and executive of clinical programs.
Proven track record of experience working with contract resource organization, functional service providers and third-party vendors
Proven track record of experience in multiple Therapeutic Areas or disease state/indications including life cycle management
Recognized leader in standard business procedures (SOPs, Global Regulations, Legal and Compliance, Outsourcing) and the application of procedures to the business. Considered a Subject Matter Expert and key contributor to initiatives. Leader and key contributor to initiatives and advancement of the clinical organization.
Bachelor’s degree in sciences or related area of study
- Advanced degree (E.g., PharmD, PhD)
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 Clinical Science
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans