Description
Clinical Site Management Lead, Associate Director - EMEA
About Astellas
At Astellas, experience is coupled energised with a relentless challenger spirit.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.
We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.
We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.
The Opportunity
As the Clinical Site Management Lead-EMEA you will be responsible 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).
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 is primarily based in the UK or EU4 major markets.
Hybrid Working
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities
- Being 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. Providing leadership/mentorship, in a matrix setting, for activities that support clinical trial teams.
- Managing and allocating monitoring resources to trials and monitor performance on assigned trials for monitoring staff (up to 12 direct reports). Taking accountability for resource planning, recruitment, mentoring, development and retention of site monitoring & management staff. Providing direction, leadership and learning opportunities to enhance individual development of direct reports in support of providing best-in-class site monitoring across the portfolio. Overseeing adherence to timelines, standards, processes for work assigned to their staff.
- Providing 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.
- Serving as a point of escalation for clinical monitoring/site management related topics or issues from their staff.
- Overseeing and providing 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.
Essential Knowledge & Experience
- Extensive experience in executing global drug development programs and trials. Strong knowledge of clinical development processes and conducting global clinical programs and up-to-date knowledge of current regulations, trends and practices in areas of support function responsibility.
- Demonstrable leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
- Proven track record of experience in working with teams to prepare for regulatory inspections including inspections readiness, participating in regulatory inspections and preparing responses to inspection findings.
- Proven extensive expertise in risk-based monitoring strategies and strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
- Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
Preferred Experience
- Experience in working in Oncology.
- Partnered with cross-functional leaders on initiatives, activities and deliverables that span across global Clinical Operations.
- Experienced in managing international employees.
- Advanced Degree.
- Fluent in English. Depending on hiring region, may also be required to be fluent in local language.
Education
- Bachelor’s degree or equivalent.
Additional Information
- This is a permanent full-time position.
- This position is primarily based in the UK or EU4 major markets.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per month in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
