Clinical Trial Lead

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).

This position 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.

Key Responsibilities:

• Managing the vendor selection, implementation, and oversight of all trial-related processes and plans in support of protocol execution and mentoring and coaching of clinical staff during execution of development trials.
• Ensuring the set-up and implementation of effective investigator and site monitor training.
• Coordinate operational and therapeutic area training for internal and external trial team members.
• Lead or oversee the development of core study documents, study plans, and systems set-up to ensure operational excellence in the execution of the clinical trial protocol and quality across investigative sites, vendors, and data
• Managing one or more trials and effectively managing and overseeing clinical trial budgets, timelines, and resources to meet the defined deliverables.
• Serving in a regional capacity to represent Clinical Operations in Key Opinion Leader (KOL) interactions, communications; Interactions, and submissions to Health Authorities within their region/country of responsibility. In these cases, they are accountable to the asset team for relevant feedback/input.

Essential Knowledge & Experience:

• Managed and led 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.
• Proactively identified and resolved issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally.
• Facilitated the site engagement and communications with investigators and/or staff to support study milestones and deliverables.
• Participates and/or facilitates 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.
• Participated in process improvement and quality-related initiatives associated with trial execution and deliverables; participated in the establishment of best-in-class processes and standards for trial conduct.

Preferred Experience:

• Significant experience in working and managing clinical trials.
• 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 the UK and US.
• This position is 100% home/remote based.

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.