Clinical Trial Lead (Addlestone, GB, KT15 2NX)

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 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.

Working Environment and Location

Reporting to the Clinical Operations Lead, this position follows our hybrid working model and requires a blend of home and a minimum of 1 day per quarter week at the Bourne office, United Kingdom. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

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.

Working Hours

40

Purpose and Scope

As the Clinical Trial 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).

Role and Responsibilities

Individuals may serve in 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.

This position may be responsible for managing one or more trials and is accountable for the effective management and oversight of clinical trial budgets, timelines and resources to meet the defined deliverables.

Represents pre/post-POC Clinical Operations at clinical extended teams or equivalent, portfolio and operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.

Manage and lead 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

Manage and lead cross-functional trial teams, including vendor set-up, performance oversight and closeout activities Responsible for 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

Ensure 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 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.

Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues, internally and externally

Continue:Role and Responsibilities

Provide input on clinical operational/development matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally

Lead preparation of vendor requirements and assess vendor capabilities to support trial scope and selection of qualified vendors; effectively manage interactions with vendor project management team Lead feasibility assessment and selection of countries and sites for trial conduct

Facilitates site engagement and communications with investigators and/or staff to support study milestones and deliverables Participates in 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

Provide accurate and up-to-date trial information in relevant tracking systems and provide regular updates of trial progression to the Clinical Operations Lead and other defined stakeholders Participates in inspection readiness activities including coordination of clinical study team deliverables

Continue:Role and Responsibilities

Individuals may serve in regional capacity to represent Clinical Operations in submissions and interactions with Health Authorities or other (external) activities as applicable

Individuals may provide regional clinical strategies directly or indirectly to asset team, in collaboration with clinical operations lead, to optimize global development strategy Facilitate and manage regional KOL interactions, as applicable

Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; support development of data review plans, review of statistical analysis plans and participate in data reviews and manage data findings

Participate in process improvement and quality-related initiatives associated with trial execution and deliverables; participate in establishment of best-in-class processes and standards for trial conduct

Provide oversight and direction to trial team members for trial deliverables, including ensuring the evaluation and implementation of patient-focused strategies for assigned trials, globally and regionally, as appropriate

Performs other duties as assigned or special projects as needed

Essential Qualifications

Bachelor’s degree in business, life sciences, or a related field or equivalent.

Extensive and demonstrable experience in the pharmaceutical industry, with proven clinical trial experience.

Must have strong knowledge of ICH/GCP guidelines and regulatory requirements

Must have strong knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.

Requires proven project management skills and trial leadership ability.

Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.

Fluent in English

Moderate (~25%) travel required

Preferred Qualifications

Advanced degree is preferred.

Why Astellas

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.

Learn more at Astellas.com

Our Organisational Values and Behaviours

Accountability

Courage

Impact

Innovation

Integrity

One Astellas

Outcome Focus

Sense of Urgency

Skills and Capabilities

Organizational Focus

Benefits

Careers | Astellas

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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