Clinical Trial Lead

Astellas; Addlestone; Hybrid; GBP 50,000 - 80,000; Full time

Job summary

A leading health partner seeks a Clinical Trial Lead in Oncology Early Development to manage clinical trials and lead cross-functional teams. This permanent position offers a hybrid working model and focuses on delivering innovative health solutions. The ideal candidate will have significant trial management experience and a Bachelor's Degree.

Benefits

Hybrid working solution

Work/life balance

Qualifications

• Significant experience in managing clinical trials within Oncology.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements.
• Must possess excellent interpersonal skills.

Responsibilities

• Managing day-to-day operations of assigned trials.
• Leading cross-functional trial teams and vendor performance oversight.
• Ensuring compliance with GCP/ICH guidelines and quality standards.

Skills

Project Management

Leadership

Communication

Education

Bachelor’s Degree

Job description

Function/Business Area

Research

Employment Class

Permanent

Description

Clinical Trial Lead (CTL) – Oncology Early Development 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 into 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. This role forms a part of the Clinical Operations, Development team. This position is based in the United Kingdom. Hybrid Working: At Astellas we recognise 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 optimise 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. 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 within Oncology across Europe or globally.
• 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:

• Bachelor’s Degree or equivalent.

Additional Information:

• This is a permanent full-time position.
• This position is based in the United Kingdom.
• 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. #LI-Addlestone #LI-Hybrid #LI-LG1