About Astellas:
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Astellas’ Global Capability Centres – Overview
Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Location and Working Environment:
This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope:
• This position is accountable for the direct management of assigned monitoring/site management related clinical trial staff across all clinical trial types, which may include pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• Accountable for the identification, onboarding, training and development of monitoring clinical trial talent to support the planning, initiation, execution and close-out of clinical trials with operational excellence. Individuals in this role will also provide leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
• This position is accountable to the Head, Early or Late-Stage Site Monitoring & Management, and will provide input into departmental budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and coaching of monitoring staff during execution of development trials.
• This position provides functional leadership and management globally of <12 direct reports.
Role and Responsibilities:
• Responsible for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff.
• Manage and allocate monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports).
• Provide direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio.
• Provide oversight and guidance in completing monitoring and site management related activities according to agreed timelines and quality standards, including identifying areas for additional training and development.
• Oversee adherence to timelines, standards, processes for work assigned to their staff.
• Serves as a point of escalation for clinical monitoring/site management related topics or issues from their staff.
• Oversee and provide guidance to Clinical Operations Leads and/or Clinical Trial Leads in regional Key Opinion Leader (KOL) interactions, communications; and submissions to Health Authorities within their region/country of responsibility, aligned to the overall asset strategy.
• Responsible for the compliance of direct reports with training and identification and support for any training needs.
• Facilitate and support global trial monitoring operational standards and tools.
• Anticipate, recognize and facilitate problem solving to support site monitoring & management staff and rapidly addresses and mitigates potential performance issues.
Continue: Role and Responsibilities:
• Collaborate effectively with Portfolio Operations Leads, Clinical Operations Leads, Center of Excellence and PECs leadership to ensure site monitoring & management staff are delivering as expected and to ensure common framework and standards across clinical programs and trials.
• Ability to collaborate with peers in Clinical Operations across Early and Late-Stage Clinical Operations, cross-functionally and regionally, including relevant counterparts globally, to align on best practices for clinical monitoring staff.
• Identify, escalate, and facilitate process improvements relevant to clinical trial monitoring and site management.
• Contribute to development and implementation of best-in-class monitoring/site management standards and processes.
• Responsible for overseeing, developing and aligning resources to ensure effective monitoring of clinical trials and a robust talent pool.
Required Qualifications:
• A BA/BS Degree required.
• Current or previous experience from a Sponsor company/Pharmaceutical industry is a must.
• Seasoned experience in executing global drug development programs and trials.
• Extensive site monitoring experience.
• Proven experience in direct people management (i.e. - CRA’s or Site Monitors, CSM’s).
• Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
• Must have extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
• Must have experience working across multiple phases of development (with a preference for late phases).
• Experience in complex monitoring (Oncology preferred).
• Demonstrated ability to successfully identify and lead global processes or system improvement initiatives.
• Must have a strong knowledge of clinical development processes and conducting global clinical programs.
• Must have proven leadership skills and effective written and verbal communication skills.
• Fluency in English is key.
• Moderate (~30%) travel required within Europe.
Preferred Qualifications:
• Advanced Degree.
• Fluency in local language/Polish is advantageous.
• Process improvement experience is a nice experience to have.
What awaits you at Astellas?
• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors:
• Impact
• Innovation
• Integrity
• One Astellas
• Accountability
• Courage
• Sense of Urgency
• Outcome Focus
Benefits:
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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