Clinical Trial Lead

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity

As the Clinical Team Lead, you will be accountable for the planning, set-up, and execution of assigned drug trials, which may include pre-/post-proof of concept (POC) interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access, and post-marketing regulatory commitment trials (interventional and non-interventional).

Your role reports to the Clinical Operations Lead and will lead the cross-functional clinical extended team to ensure efficient and compliant clinical trial set-up, execution, and delivery of assigned trials. Your role forms a part of the Clinical Operations, Development team. Your position is based in either the UK or Poland.

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

• Managing and leading the day-to-day operations of assigned trials to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Managing and leading cross-functional trial teams, including vendor set-up, performance oversight, and closeout activities.
• Ensuring oversight and guidance to clinical study team members in completing deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned studies.
• Leading or overseeing the development of core study documents, study plans and systems set-up to ensure operational excellence in execution of the clinical trial protocol and quality across investigative sites, vendors and data.
• Participating in and/or facilitating cross-functional collaboration and strategic problem solving to ensure risk mitigation, appropriate progress and timely completion of trials and deliverables according to established objectives, milestones and goals.
  
  

Essential Knowledge & Experience

• Significant experience in working on and managing clinical trials.
• Proven project management skills and trial leadership ability.
• Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements
• Excellent interpersonal, written, and verbal communication skills, administrative skills, and computer ability.
• Preferred Experience:
• Strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
  
  

Education/Qualifications

• Bachelor’s degree or equivalent.
  
  

Additional Information

• This is a permanent, full-time position.
• This position is based in either the UK or Poland
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter 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.