Portfolio Operations Lead, Early Development Oncology

Astellas - (Contractor) - Northbrook, IL

Full-time - Mid Level

Remote - Northbrook, IL

About the position

The Portfolio Operations Lead for Early Development Oncology at Astellas is a pivotal role that oversees and provides strategic direction across pre- and post-proof of concept (POC) development programs. This position is integral to the execution of multiple cross-therapeutic, global clinical drug development programs, which may encompass various therapeutic areas such as Oncology, Immuno-Oncology, rare diseases, and Biopharma, including cell and gene therapies. The role may also extend to managing digital and combination drug-device therapeutics. In this capacity, the Portfolio Operations Lead is responsible for ensuring consistent strategic input and operational insight across assets in their primary focus area of development. This includes oversight of Clinical Operations Leads and core development plans, such as the Integrated Evidence Generation Plan (iEGP), Global Development Plan (GDP), Clinical Development Plan (CDP), and patient-focused strategies. The position may also involve representing Clinical Operations in due diligence activities, providing expert input on Clinical Development Plans, operational strategies, and budget and timeline assumptions. As a member of the extended Clinical Operations leadership team, the Portfolio Operations Lead contributes to departmental structure, budget and resourcing strategies, and the development and oversight of global processes and procedures. Additionally, this role includes training, coaching, and mentoring of staff, both direct and indirect, ensuring that clinical development teams adhere to established operational standards, approved budgets, and timelines. The Portfolio Operations Lead is also tasked with proactively identifying and managing operational risks that may arise during program and trial conduct, engaging in strategic problem-solving and contingency planning with key cross-functional leadership and stakeholders to ensure timely completion of trials and program deliverables. This position is considered a Subject Matter Expert in process improvements, clinical program development strategy, and clinical trial execution, and plays a crucial role in fostering collaboration between Early and Late Stage Portfolio Operations Leads.

Responsibilities

• Oversee and provide strategic direction across pre/post-POC development programs.
• Ensure consistent strategic input and operational insight across assets in the primary focus area of development.
• Manage Clinical Operations Leads and core development plans, including iEGP, GDP, and CDP.
• Represent Clinical Operations in due diligence activities, providing expert input on Clinical Development Plans and operational strategies.
• Accountable for clinical development teams working within established operational standards, budgets, and timelines.
• Proactively identify and manage operational risks during program and trial conduct.
• Engage with key cross-functional leadership in strategic problem solving and contingency planning.
• Ensure project teams evaluate and incorporate operational strategies with a patient focus.
• Participate in governance committees internally and with external vendors and partners.
• Oversee coordination of relationships during integrations or partner collaborations for clinical work.
• Collaborate closely with Early and Late Stage Portfolio Operations Leads to provide strategic and operational input during asset transitions.
• Identify, evaluate, and advance innovative operational strategies to increase productivity and efficiency.
• Develop and implement cross-functional and cross-regional strategies for operational alignment across the global Clinical Operations organization.

Requirements

• Experience in clinical operations and drug development, particularly in oncology or related therapeutic areas.
• Strong leadership skills with the ability to manage and mentor teams effectively.
• Proven track record in managing clinical trial budgets, timelines, and resources.
• Expertise in strategic problem solving and contingency planning.
• Ability to interact with cross-functional teams and stakeholders at various levels.
• Strong understanding of regulatory requirements and compliance in clinical trials.
• Excellent communication and interpersonal skills.

Nice-to-haves

• Experience with digital and combination drug-device therapeutics.
• Familiarity with cell and gene therapies.
• Previous experience in a global clinical operations role.

Benefits

• Health insurance coverage
• Dental insurance coverage
• 401k retirement savings plan
• Flexible scheduling options
• Paid holidays and vacation time
• Professional development opportunities
• Remote work options available in certain states