About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing 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 caregivers, 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:
An exciting opportunity to contribute to pivotal trial launches and new programs, where we welcome fresh ideas and innovative ways of working — giving you the chance to share your expertise and make a meaningful impact on our processes.
In this position, you will be accountable for the oversight and execution of assigned pre/post-POC interventional drug programs, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
Be accountable to the Portfolio Operations Lead and clinical operations leadership team and will provide input into budget and resourcing strategies, including development and implementation of global processes and procedures, non-drug product initiatives, and mentoring and coaching of staff during execution of development trials.
The position has accountability for assuring strategic input and operational insight into the asset development planning lifecycle, including integrated evidence generation (iEGP), Global Development Plan (GDP), Clinical Development Plan (CDP) and the implementation of patient-focused strategies for assigned programs.
Represents pre/post-POC Clinical Operations in Asset Teams, Portfolio and Operational review meetings, primary focus area governance, and cross-functional process improvement projects, as applicable.
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.
The position may also represent Clinical Operations in due diligence activities for assets that may be in-licensed or acquired.
Reporting to the Portfolio Operations Lead (or above), you will lead a global team of 2 – 3 direct reports, including international team members.
Hybrid Working:
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.
Key Activities For This Role:
- Responsible for effective planning, oversight, and execution of Clinical Development Plans and pre/post-POC trials for assigned assets and due diligence projects.
- Ensure expert clinical operations strategy input is provided to Primary Focus Area and/or Asset Teams.
- Develop clinical program budgets and resource estimates for assigned assets and due diligence projects.
- Provide oversight of budget and resources during execution of clinical trials.
- Provide oversight and guidance to extended team members in completing program deliverables according to agreed timelines and quality standards, including awareness and escalation of high impact quality-related topics for assigned programs.
- Provide input on clinical operational matters for interactions with regulatory authorities and key opinion leaders, either globally or regionally, as applicable.
- Participate 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.
- Work with teams to proactively identify and manage operational risks that arise during program and trial conduct, including escalation to Primary Operations Lead, functional management, and external vendor management to accelerate mitigation (as appropriate).
- Ensure close collaboration between Early and Late-Stage Clinical Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development.
- Anticipate, recognize and drive problem solving to rapidly address and mitigate emerging program or trial risks.
- Encourage individuals in investigating and applying clinical best practice methodologies in program(s) and clinical trials.
- Represent Clinical Operations in inspection readiness activities including coordination of trial team quality deliverables.
- Provide oversight and direction to trial team members for evaluation and implementation of patient-focused strategies for assigned trials.
- Participate in resource allocation across the department as required for portfolio delivery and non-drug project initiatives/process improvements.
- Acts as a change champion for Clinical Operations across the global organization.
- Responsible for compliance of direct reports with Astellas policies, procedures, and all associated training.
- Responsible for overseeing the development and management of department and program budgets, resources and timelines for assigned assets.
Essential Knowledge & Experience:
- Seasoned experience executing complex global drug development programs and trials.
- Demonstrated experience working in late-stage development.
- Current or previous experience within the Oncology therapeutic area is essential.
- Must have strong knowledge of ICH/ GCP guidelines and multinational clinical trial regulations.
- Demonstrated ability to successfully identify and lead global process or system improvement initiatives.
- Must have a strong knowledge of clinical development processes and conducting global clinical programs.
- Demonstrated leadership skills and ability to effectively collaborate with colleagues in Clinical Operations and cross-functionally to deliver on portfolio deliverables and objectives.
- Must have proven leadership skills and effective written and verbal communication skills.
- Fluent in English.
- Moderate (~25%) travel required, depending upon assigned program and phase.
Preferred Experience:
- Direct people management or leadership experience is key.
- Ability to thrive in a collaborative, cross-functional environment — working effectively with a range of teams, roles, and personalities.
- Comfortable to also work independently, showing initiative and resourcefulness to problem-solve and exchange ideas with colleagues.
- Flexibility and the ability to manage multiple priorities.
Education:
- BA/BS Degree or an Advanced Degree.
Additional Information:
- This is a permanent, full-time position, based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in office. Flexibility may be required in line with business need.
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.
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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