Astellas Pharma Associate Director Clinical Science Center of Excellence-Legal Operations in Northbrook, Illinois
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing an Associate Director Clinical Science Center of Excellence-Legal Operations opportunity in Northbrook, IL.
Position & Scope:
This position is accountable for the coordination and execution of work within the Clinical Science Legal Operations support function.
This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant legal requirements and global data privacy matters in the support of clinical trial execution/oversight that adhere to Astellas and GCP/ICH requirements and are developed in close collaboration with Astellas Legal/Data Privacy Organizations.
This position is accountable for the efficient delivery of site/investigator clinical contracts, informed consent language and other general legal language guidance for clinical site operational documents that maintain compliance, operational and legal standards, while ensuring contracts are delivered in a timeline manner to meet study/project timelines.
This position may have responsibility for the interaction and coordination of cross- functional and cross regional strategies to ensure operational alignment within Medical and Development and between the clinical organizations in Japan and China for the relevant support functions.
This position is a member of the Clinical Science Management team.
Essential Job Responsibilities:
- Responsible for oversight of negotiations with clinical investigator sites and others as needed to facilitate master clinical trial agreements/ clinical trial agreements ensuring that contract language provided to vendors aligns with the expectations of established Astellas legal positions
- Responsible for appropriate review of escalated clinical site Informed Consent Documents and other patient facing materials as needed to ensure compliance with applicable global legal/ regulatory requirements
- Develop and maintain processes to facilitate the ability to effectively oversee and manage the day-to-day operations and deliverables of internal and external site contracting escalation processes per established practices, guidance documents, agreements and objectives in compliance with applicable GCP/ICH guidelines and other requirements.
- Serve as primary liaison to collaborate between business and designated legal partners to support 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
- Actively manages resources (contract and permanent) within support function, including recruitment, development / career management (permanent staff only) and retention of staff.
- 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.
This position reports to the Director, Clinical Science or above. May be responsible to manage up to 10 direct reports, including oversight of contractors.
While this position resides in Development, the scope of responsibility for this role include support of broader M&D functions, including Medical Affairs and Rx+.
- Law Degree (Juris Doctor).
- At least 5 years prior legal experience handling contractual/ transactional legal matters with at least 2 years directly involved with a company within the pharmaceutical/ biotechnology industry.
- Good understanding of the legal and data privacy issues affecting the pharmaceutical industry, including GDPR, regulatory processes for prescription drugs, anti-kickback, fraud and abuse, anti-bribery and anti-corruption and antitrust laws, IP, manufacturing, R&D, regulatory and commercial element.
- Strong ability to grasp 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.
- Minimally, experience in managing contract resources
- 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
- Direct people management experience
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Clinical Science