Portfolio Operations Lead

4 months ago

Addlestone, United Kingdom Astellas Pharma Europe Full time

**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 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 a Portfolio Operations Lead, your role is to provide strategic direction for pre
- and post-POC (Proof of Concept) development programs. This includes overseeing the execution of multiple global clinical drug development programs across different therapeutic areas such as Oncology, Immuno-Oncology, rare diseases, and Biopharma, including cell and gene therapies. You will also manage Clinical Pharmacology trials involving normal healthy volunteers, pre-approval access, and post-marketing regulatory commitment trials, both interventional and non-interventional.

Additionally, your responsibilities extend to digital and combination drug-device therapeutics. You'll ensure consistent strategic input and operational insight across assets within your primary focus area, working with Clinical Operations Leads on core development plans like the Integrated Evidence Generation Plan, Global Development Plan, Clinical Development Plan, and patient-focused strategies.

In this role, you may represent Clinical Operations in due diligence activities, offering expert input on development plans, operational strategies, budgeting, and timelines. As a member of the Clinical Operations leadership team, you'll contribute to departmental structure, budgeting, global processes, and staff development through training, coaching, and mentoring. You will be part of an inclusive team that works to develop innovative therapies for patients.

**Hybrid Working**:
At Astellas, we recognise that our employees enjoy having a balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

**Key Activities for this role**:

- Accountable for assuring that clinical development teams are working within established operational standards, approved budgets, and timelines.
- Work with teams to proactively identify and manage operational risks that arise during program and trial conduct across assets within their primary focus area, including escalation to functional management and external vendor management to accelerate mitigation (as appropriate).
- Interact with key cross-functional leadership/stakeholders in strategic problem solving and contingency planning to assure progress and timely completion of trials and program deliverables according to established asset objectives, milestones, and goals.
- Responsible for ensuring project teams are consistently evaluating and incorporating operational strategies with a patient focus on reducing burden and enhancing the experience of trial participants and site.
- Ensure close collaboration between Early and Late-Stage Portfolio Operations Lead(s), including providing strategic and operational input during development and as the assets transition from early to late-stage development.
- Responsible for identifying, evaluating, and advancing innovative operational strategies aimed at increasing productivity, efficiency and quality while decreasing cycle times and cost.

**Essential Knowledge & Experience**:

- Must have multi-trial global experience in a leadership role.
- Experience in multiple therapeutic areas or disease state/indications, including life cycle management and due diligence.
- Demonstrated people management experience is a must.
- Must have demonstrated extensive expertise in developing clinical development strategies and strong knowledge of ICH/GCP guidelines and multinational clinical trial guidelines (including operationa

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