Site Contract & Budget Lead II

Astellas Pharma • Northbrook, IL

16h • Remote

About The Position

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 [https://nam12.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.astellas.com%2F&data=04%7C01%7Cseth%40recruitrooster.com%7C59d7121876474762797c08d92ce14af5%7Cf4e1fd9942ea4d61957ae47394505924%7C1%7C0%7C637590168405503237%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=iaBVZrKeN7JRw3YZwXpqm%2FiJYBkbTiB0bxaXAq7xeLw%3D&reserved=0].   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: Coordination and execution of work within the Site Contract, Budget support function in support of both early and late-stage Clinical Operations and may include support for other functions (Medical Affairs). This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant regulatory, legal requirement and global data privacy requirements in the support of clinical trial execution that adhere to Astellas and GCP/ICH requirements. This position will collaborate with Astellas Legal/Data Privacy Organizations, Ethics & Compliance and other external stakeholders as required. This position will contribute to project level timelines and will report on performance timelines both during feasibility and throughout the lifecycle of contract/budget negotiation. This position is accountable for the efficient delivery of core and country templates for clinical site operational documents that maintain regulatory and corporate compliance, operational and legal standards, while ensuring contracts are delivered to meet study/project timelines. This position may be responsible for managing direct reports and may additionally include oversight of contractors.

Requirements

• Bachelor’s Degree or equivalent relevant experience
• At least 10 years prior experience handling and executing on functional specific material (e.g. contracts, budgets, payments or informed consent form) matters with at least 5 years directly involved with a company within the pharmaceutical/ biotechnology industry. Global experience preferred.
• Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates.
• Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice.
• Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner.
• Must have a strong knowledge of clinical development processes and ICH/GCP
• Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant non-project support functions.
• Must have excellent interpersonal, written, verbal, and computer skills.
• Minimal (10-20%) travel required
• Fluent in English

Nice To Haves

• Direct people management experience is preferred

Responsibilities

• Responsible for development of final processes, standards and tools for utilization within either both Site Contracts and Site Budget or a specific area of focus (e.g. Site Contract or Site Budget, including global implementation with the project team.
• Draft of guidance documentation(s) and training.
• Manages the changes of the documents, templates or training under their purview.
• Serves as primary liaison to collaborate between business and designated legal partners (as needed) to support development of global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business.
• Participates in strategic improvement/innovation projects as requested.
• Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies related to these positions.
• Support for Industry Best Practice investigation and implementation.
• Support for development of related metrics for functional area, including measurement, and monitoring including recommendations to enhance performance of study start up.
• Management of any CRO resources necessary for study delivery.

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
• Company fleet vehicle for eligible positions
• Referral bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees