Director, US Portfolio Delivery (cross-TA)

At [Employer], we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. [Employer] fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together.

Job Purpose

Director, US Portfolio Delivery (cross-TA) provides leadership, oversight and local US delivery of studies in support of global R&D programs. The LDL-Director is accountable for a portfolio of assets, and manages the activities of US Program Leads (PLs) and US Local Delivery Leads (LDLs) to ensure the delivery of all clinical studies, across therapeutic areas to the required quality standards, [Employer] written standards and ICH GCP. The LDL-Director operates independently and effectively in a highly complex, high volume, strategic market.

Key Responsibilities:

• Leads a team of PLs and LDLs operating in a highly complex environment due to scale (number of subjects/sites per study) and volume of studies conducted, providing training, coaching, mentoring, line and performance management.
• Responsible for effectively managing capacity utilization of LDL resources and contributes to resourcing solutions including multi-country support by LDLs, ensuring alignment of capabilities with study requirements, resource availability and business priorities. Contribute to overall management of clinical research within the LOC via involvement in applicable leadership teams to ensure consistency and utilization of resources and best practice.
• Accountable for ensuring the completion of all project management deliverables for all studies assigned to the LOC to agreed timelines, budget and quality standards. The LDL manager works with the LDLs to identify and resolve or escalate risks and issues that may impact study delivery.
• Responsible for identifying and sharing best practices, standardizing across the LOC / region and representing local/regional clinical operations on global and cross functional initiatives. Ability to understand and respond to unique challenges in managing workload due to size and scale of studies.
• Recruits and develops LDLs. Evaluates capabilities and competencies of internal staff, identifies and coordinates implementation of personal development plans for direct reports.
• Partners with local and central teams to ensure robust study feasibility with reference to study complexity, clinical facilities and monitoring resource.
• Establishes and manages key strategic relationships with external vendors to ensure clinical studies are appropriately resourced and executed as necessary.
• Ensures that critical study timelines related to study activities are accurately forecasted and achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are met. Provides trouble-shooting and problem resolution support for LDLs to ensure productive, efficient study delivery.
• In collaboration with Clinical Operation Director and Local/Regional Quality, Capability & Risk Manager identifies management monitoring process checks linked with LDL activities that require inclusion in the local quality plan to ensure quality and integrity of clinical studies conducted in the LOC.
• Assists with audits/inspections of local clinical operations department & study / sites in the country, as required.
• Continuous development of knowledge in the areas of GCP, internal company guidelines, SOPs, new monitoring technologies and capabilities. Serves as an expert in ICH GCP and [Employer] written standards for LDLs.
• Leads or participates in regional/global clinical operations projects (as appropriate).
• Available and willing to travel as job requires.

Why You?

Basic Qualifications:

• University degree in Sciences (Medicine, Pharmacy, Biochemistry, Biology or related fields) or equivalent demonstrable professional experience in the area
• At least 10 years of experience in clinical operations delivery within the pharmaceutical or biotech industry, including leadership of complex, multi‑site clinical studies in the US.
• At least 5 years of experience leading and developing clinical operations leaders or managers (e.g., LDLs, study managers, CTMs) in a high‑volume, high‑complexity environment.

Preferred Qualifications:

• Demonstrated accountability for study delivery to timelines, quality standards, and regulatory requirements, including risk identification, issue escalation, and problem resolution.
• Strong working knowledge of ICH‑GCP, [Employer] written standards, and US regulatory expectations.Experience delivering HIV, respiratory and/or hepatology clinical trials in the US
• Experience working with site networks and referral networks
• Experience partnering with Patient Advocacy Groups
• Experience leading delivery across late phase and/or registrational studies.

Skills

Please visit [Employer] US Benefits Summary to learn more about the comprehensive benefits program [Employer] offers US employees.

Why [Employer]?

Uniting science, technology and talent to get ahead of disease together.

[Employer] is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

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Originally posted on [Employer]