The Senior Director, TA Strategy and Portfolio Delivery (R&I) leads the development and implementation of global Site Management & Monitoring (SMM) Therapeutic Area strategies, shaping how the portfolio is delivered across all phases. Working closely with Indication Program Leads, Directors and Associate Directors of Strategic Feasibility, and Study Operation Leads, this role aligns strategic objectives, builds end-to-end capability and drives operational excellence across countries and geographies.

Acting as a key member of the global SMM Business Strategy and Portfolio team, this leadership role connects SMM insights with global TA strategy. It coordinates portfolio performance and ensures that SMM countries are equipped to deliver against critical achievements while embracing innovation in digital health and patient-centric solutions.

Key Responsibilities:

• Lead the establishment and implementation of global SMM TA strategies, ensuring alignment of capacity and capability in the short and long term across the clinical portfolio.

• Develop and integrate end-to-end capability for early to late phase clinical portfolio execution, ensuring seamless transition and delivery across phases.

• Interface with global teams to shape TA strategy and translate it into clear, actionable plans at market level.

• Maintain strong awareness of emerging trends in strategic portfolio management and development, both internally and externally at a global level, and apply these insights to SMM strategy.

• Build indication landscaping and future portfolio plans with Indication Program Leads, Directors and Associate Directors of Strategic Feasibility to ensure teams are prepared for delivery.

• Ensure alignment between Global SMM and Country Heads by communicating projected study volumes, timelines and strategic priorities to support tailored local strategies and accurate resource planning.

• Act as the subject matter expert for SMM within global cross-functional workstreams and taskforces, providing strategic insights and guidance to drive collaborative decision-making and project outcomes.

• Provide robust global SMM insights to support indication landscape assessments, study design evaluation and protocol/site feasibility, ensuring country feasibility outcomes are embedded into operational plans.

• Collaborate closely with IPLs, DSFs, ADSFs, SOLs and relevant global teams to optimise country and site selection for TA studies.

• Use bottom-up country strategy combined with TA expertise to advise on optimal countries and sites for feasibility participation.

• Define and standardise optimal feasibility processes in collaboration with IPLs, DSFs and Study SOLs to drive consistency and quality.

• Drive delivery, review and discussion of the TA portfolio within SMM and with global teams, ensuring transparency on progress and priorities.

• Escalate issues and mitigate risks for new and ongoing studies to secure business-critical milestones such as recruitment completion, database lock and reduced study cycle times.

• Provide ongoing visibility of the TA portfolio and organisational capacity, influencing decisions through Regional Directors to optimise resources within SMM in both the near and longer term.

• Champion digital health solutions, patient-centric approaches, and recruitment and retention strategies for TA studies, aligned with global initiatives.

• Engage internally and externally to identify potential new investigators, expanding the global footprint in line with TA clinical development plans.

• Drive standardisation within SMM for feasibility conduct, site selection, operational projections and processes to enable consistent high-quality delivery.

• Demonstrate cultural sensitivity, effective communication, negotiation and collaboration across diverse teams and geographies.

Essential Qualifications:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification aligned to the knowledge and skills of the role and ensures successful conduct of responsibilities and appropriate interactions with internal and or external stakeholders.

• Previous experience in the pharmaceutical industry.

• Strong leadership and management skills, with the ability to motivate and develop a high-performing team.

• Excellent communication and interpersonal skills, with the ability to build strong relationships with internal and external stakeholders.

• Strong analytical and problem-solving skills, with the ability to interpret complex data and develop effective solutions.

• Ability to travel nationally/internationally as required.

• Relevant knowledge and ability to fulfil key responsibilities, including but not limited to: drug development process and related GxP processes, international guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, clinical study management, strategic portfolio management, functional management of resourcing, budget planning and functional level activities.

Preferred Qualifications:

• Clinical Operations experience.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and ambitious world.

The annual base pay (or hourly rate of compensation) for this position ranges from $206,993.60 - $310,490.40 USD. Our positions offer eligibility for various incentives,an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include qualified retirement programs, paid time off (i.e., vacation, holiday, and leaves), as well as health, dental, and vision coverage in accordance with the terms of the applicable plans.

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Accountabilities

• Hold overall accountability for meeting country-level study commitments, ensuring timely delivery of high-quality data.
• Lead Local Study Teams for assigned studies, including CRAs, CSAs and other contributors, promoting collaboration, clarity of roles and strong performance.
• Drive optimal performance and compliance of Local Study Teams with AstraZeneca Procedural Documents, ICH-GCP requirements and local regulations.
• Oversee high-quality clinical and operational feasibility assessments for potential studies, providing robust input into study selection and design.
• Coordinate and manage the site selection process, including identification of potential sites and investigators, initial site quality risk assessments and, where needed, Site Qualification Visits to assess suitability and quality risk.
• Ensure timely submission of applications and documentation to Ethics Committees/IRBs and, in partnership with Regulatory Affairs, support delivery of submissions to Regulatory Authorities in line with local requirements.
• Prepare accurate country-level financial agreements and maintain current study budgets within the clinical financial system, working closely with Director SMM or Director Country Head and Clinical Finance as appropriate.
• Ensure effective set-up and ongoing management of studies within CTMS, eTMF, study finance systems and any other tools or local platforms required by country-specific laws and processes.
• Oversee, manage and coordinate all monitoring activities from site activation to closure according to Monitoring Plans, reviewing monitoring visit reports and providing guidance and support to monitors.
• Conduct co-monitoring visits, accompanied site visits and training visits with study CRAs to drive quality, consistency and development.
• Proactively identify risks, facilitate rapid resolution of complex study issues and escalate when necessary.
• Organize and lead regular, agenda-driven Local Study Team meetings that enable transparent communication, issue resolution and aligned decision-making.
• Build and maintain strong working relationships with Local Study Team members, site staff and global stakeholders to support smooth study execution.
• Report study progress, milestones, risks and mitigation plans to the Global Study Associate Director, Global Study Team and SMM/Study Operations Lead as applicable.
• Contribute to patient recruitment strategies and maintain regular contact with investigators to support enrolment targets.
• Develop, maintain and review a study-level country risk management plan, managing sites, stakeholders, vendors and customers to ensure timely risk identification and mitigation.
• Coordinate closely with National Coordinating Investigator or National Lead Investigator on recruitment and other key study matters where applicable.
• Plan and lead National Investigator Meetings in line with local codes when required.
• Support forecasting for study timelines, resource needs, recruitment, budgeting, materials and investigational product supply.
• Ensure set-up, updating and access to business-critical systems for Safety Reporting, Regulatory Submissions and Clinical Trial Transparency at country level.
• Ensure accuracy and compliance of all study payments in accordance with local regulations and agreements.
• Participate in training and coaching of new Local Study Team members to ensure quality delivery and adherence to ICH-GCP and AstraZeneca procedures.
• Maintain the study eTMF in an inspection-ready state at all times, ensuring documentation is complete, accurate and current.
• Plan and lead audit and regulatory inspection activities in collaboration with the Clinical Quality Associate Director and Quality Assurance teams.
• Contribute insights to process development and continuous improvement initiatives across the organization.
• Keep line managers regularly informed about study status, milestones, key issues and team performance.
• Ensure full compliance with local policies, codes of ethics and business practices in all study-related activities.
• Provide feedback on research trends, competing studies and site/investigator insights that can inform local strategy.
• Collaborate with the local Medical Affairs team as needed to support optimal study delivery and scientific quality.
• Actively support SMM initiatives at local, regional or global level as agreed with line management.

Essential Skills/Experience

• Bachelor’s degree in related discipline with 5+ years of previous experience in the pharmaceutical industry
• Relevant knowledge and ability to fulfill key responsibilities, including but not limited to:

+ Drug development process and related GxP processes, International guidelines ICH-GCP, relevant country regulations, medical knowledge and ability to learn relevant AZ Therapeutic Areas, Clinical Study Management including project management, monitoring, study drug handling and data management. + Personal Effectiveness & Drives Accountability in Others + Learning Agility + Financial, Technology & Process Competency + Active Listening, Fluency in written & spoken business-level English + Act with Integrity & high ethical standards + Effectively lead a team across in-person and virtual settings to deliver shared goals, demonstrates cultural awareness + Identify and champion more efficient delivery of quality clinical trials with optimized cost and time + Ability to travel nationally/internationally as required + Valid driving license, if country employment requirement + Communication & Teamwork – Influencing, Collaboration, Impactful Site conversations + Effective, risk-based thinking – Plans & Aligns, Strategic thinking, Problem Solving, Critical Thinking, + Decision Making, Effective Issue Management + Clinical Study Operations (GCP) & Quality Management – RbQM: Interpreting and implementing the Monitoring Plan, Study site selection & set-up + Deliver Priorities Results & Impact – Project Management, Recruitment/Retention Planning & Action

Desirable Skills/Experience

• Bachelor's degree in the life sciences field is preferred
• Previous experience in Clinical Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies) is a plus

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Performing identification, selection, initiation, monitoring, site data review and closeout activities/visits, as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).

Driving performance at the sites by proactively identifying and ensuring timely resolution to study-related issues and escalating them as appropriate.

Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.

Developing recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Documenting recruitment barriers and implementing mitigation plans.

Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.).

Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator, including follow-up letters, within required timelines and in line with Alexion SOPs.

Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements. Supporting/participating in regular QC checks of the eTMF.

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include collection, preparation, review, and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.

Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed.

Following quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to Global Study team, Local study team, Country Operations Line Management, and/or Quality Group, representatives as required.

Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, Country Operations Line Management, and Quality Group.

Required qualifications include:

Minimum of 1 year of CRA monitoring experience

Bachelor's degree in a related discipline, preferably in life science, or equivalent qualification

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP

Excellent knowledge of relevant local regulations

Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas

Good understanding of the drug development process

Excellent understanding of Clinical Study Management, including monitoring, study drug handling, and data management

Excellent attention to details

Excellent written and verbal communication skills

Excellent collaboration and interpersonal skills

Good negotiation skills

Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

Valid driving license (dependent on country requirements)

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