When we put unexpected teams in the same room, we unleash ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform 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 unique and ambitious world.

The Global Study Associate Director (GSAD) is a business-critical role whose main accountability is the delivery of clinical studies. The GSAD is responsible to lead a cross-functional study team and provide the team with direction and guidance to enable successful study delivery. The GSAD is accountable to the GPT for the delivery of a study according to agreed upon timelines, budget, and quality standards by ensuring an effective partnership and teamwork within study team and/or external partners.

The GSAD leads the study team in accordance with the Rare Disease Study Team Operating Model for Internal Delivery (rSOLID) and/or clinical outsourcing model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and protocols (e.g. job aides, guidelines), and in line with Alexion’s mission, values, and behaviours.

Studies may be across various therapeutic areas and all phases (I-IV, including Late Phase, Non-Interventional, Post Authorization Safety Studies, Registries, Early Access Programs, etc.).

You will be responsible for:
Lead and coordinate a cross-functional study team of experts in accordance with rSOLID and its roles, accountabilities, and responsibilities framework (RACI) to ensure the clinical study progress as planned, driving achievement of landmarks according to timelines, budget, and quality standards.

Develop and maintain relevant study documents/plans (e.g., global study management plan and its relevant components, etc.) including required input into clinical study protocol, clinical study report, and study level quality and risk management planning (e.g., risk-based quality management, proactive risk and contingency plans, inspection readiness plans, etc.).

Lead and facilitate communication across all functions and provide guidance and support to the core and extended study team members as needed
As the leader of the Clinical Trial Team (CTT), is the main point of contact for the Global Project Team (GPT) and the Clinical Sub-Team (CST).

Accountable for study performance against agreed upon plans, landmarks, and key performance indicators (critical metrics, quality and operational).
Maintain study tracking systems and project timelines (e.g., PLANIT, CTMS, TMF dashboard, etc.) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations.

Identify and report quality issues that have occurred within the study in accordance with relevant SOPs and collaborate with all functions as necessary to overcome barriers and achieve landmarks; proactively communicate findings and corrective action plans (CAPAs) to relevant collaborators (e.g., CPT, quality assurance staff, functional line management, etc.).

Oversee TMF completion in accordance with relevant SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times.

Ensure timely compliance with company-wide governance controls (e.g., Delegation of Authority, Sunshine Act, Clinical Trial Transparency, etc.).

Ensure studies are inspection-ready at all times, according to ICH-GCP, SOPs, and relevant policies/guidelines. Primary Clinical Operations point-of- contact in the event of an audit or inspection.

Ensure that the risk response strategies and issue customer concern pathways are clear to the entire study team.

For outsourced studies, be the primary Alexion point of contact for the CRO Project Manager to ensure study delivery according to agreed upon timelines, budget, and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g., description of services, transfer of obligations, etc.).

Ensure all external service providers (e.g., central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented.

Accountable for planning, tracking and forecasting the Global Clinical Operations budget and timelines for the studies against the agreed goals. Develops and maintains budgets for study(s) that include short and long-range clinical forecasting and monthly accruals based on clinical activity to support Clinical Development financial goals, and identifying any financial risks and mitigation plans (as a part of the ongoing study change control process).

Delegate and be responsible for team member responsibilities.
Conducts lessons learned exercises to provide continuous process improvement and sharing of procedures.

Work on non-drug project work such as Clinical Operations representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager.

Works with global and country teams to determine appropriate country footprint for the study, including consolidation of information from country teams to support internal governance approvals for the study.

Leads and coordinates Key External Expert (KEE) outreach activities to assess study design suitability and/or find opportunities for protocol improvement.
Partners closely with Strategic Feasibility to develop country and site footprint proposals and patient enrolment projections for endorsement by Global Program Team (GPT).

Maintains global oversight of study deliverables, landmarks, and site monitoring throughout the study lifecycle.

Works with global and country-level collaborators to mitigate risks or issues related to site management and monitoring as they arise.

Support other study and functional activities, as assigned.

You will need to have:- 7 years of clinical research experience, 2 of which in a leading role accountable for the planning and execution of global clinical trials.

- Bachelor’s degree or equivalent, in one of the fields related to clinical practice/health care, life sciences, or drug development, or commensurate work experience.

- Extensive knowledge of clinical research regulatory requirements and demonstrated abilities in clinical study management processes and clinical/drug development.

- Stong, demonstrated abilities/skills in team leadership.

- Strong abilities in establishing and maintaining effective working relationships with internal and external co-workers and collaborators, along with strong conflict management skills.

- Excellent communication and interpersonal skills.

- Strong strategic and critical thinking abilities.

- Strong organizational and problem-solving skills.

- Ability to handle challenging priorities.



The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

Desirable Skills/Experience:- PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.

- Experience with global clinical studies and regulatory submissions.

- Ability to establish excellent internal and external relationships, including alliance partners and vendors.

- Supportive teammate who shines in a collaborative environment.

- Well-developed sense of ethics, responsibility, and respect for others.

- Agile learner with ability to work both collaboratively and independently, seeking advice as required.

- High level of flexibility and ability to innovate and adapt to changing conditions.



At Alexion, you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a relevant difference in patients' lives.

Ready to lead and inspire? Apply now and take the first step towards a fulfilling career at Alexion, AstraZeneca Rare Disease.

#LI-Hybrid⠀
Annual base salary for this position ranges from 121,562.40 to 159,550.65.AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs.  In some cases, offers outside the range may also be considered to address unique circumstances.

In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role).  Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks’ paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

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At Alexion, AstraZeneca Rare Disease, we are driven by innovation, leadership, and collaboration. Our mission is to tackle the toughest challenges and make a real difference for individuals living with rare and devastating diseases. The Global Marketing and Market Access team (GMMA) is pivotal in crafting disease and brand commercial strategies, developing global marketing materials, and... negotiating strategies. We work closely with markets to ensure successful implementation. Our team monitors business performance and strategy effectiveness, positioning our brands for long-term success. We also deliver commercial strategies for pipeline programs and establish marketing strategies for new product launches. Our culture thrives on collaboration, authenticity, creativity, and pushing boundaries to advance patient care.
You will be responsible for:
Early Commercial Strategy Development:- Drive evidence generation strategies and timely deliverables to inform a differentiated target product profile (TPP) and value proposition across customer segments.- Serve as the global commercial representative for GPT/eGPT and relevant subteams providing commercial analysis, input, and leadership for product development and commercialization.- Establish the brand vision, revenue forecast, and life-cycle management plan including indication prioritization and sequencing to realize full potential of asset.- Ensure endorsement of the commercial strategy and forecast assumptions at governance bodies including Forecast Review Committee (rFRC) and TA Forum.- Set the commercial strategy and business case for investment decisions into candidate development (CDID) and Phase 2 (P2ID).

Early Therapeutic Area Strategy Development:- Partner with Research, Development, and the commercial TA to identify indications in scope for new targets in prioritized indications.- Engage with Key External Experts (KEEs) to establish the unmet need, competitive environment, early TPP, and value proposition to inform new target selection and preclinical plans.- Set the commercial strategy for investment decisions into new targets (TSID) and candidate selection (CSID) at the Research Steering Committee (RSC).

Business Development:- Serve as commercial lead on the cross-functional Due Diligence team and establish global commercial evaluations of external in-licensing opportunities that could support the TA strategy.- Collaborate closely with Business Development Operations function.
You will need to have:- Bachelor’s degree is required in Business, Medical or Life sciences.- Significant experience in healthcare, biopharma industry or consulting, with a strong preference for experience in oncology.- Significant and in-depth understanding of global commercial strategy, methodologies and tools (product profiling and positioning, forecasting, pricing and reimbursement, market research techniques, competitive intelligence resources).- Experience of crafting brand strategy whilst the understanding of product profile was incomplete and evolving.- Detailed ‘hands-on’ knowledge of building TPPs, generating sales forecasts and business cases.- Thorough understanding of the drug development process and the need for commercial line of sight throughout.- Understanding of future healthcare market challenges.- Strong interpersonal and team leadership skills, demonstrating flexibility and a validated ability to deal with complexity under time pressure.- Proven strong influencing skills and stakeholder management.- Experienced and comfortable working in a matrix environment.- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:- An advanced degree (MBA, MD, MSc or PhD).- Significant experience leading commercial evaluation of BD projects.

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 unique and ambitious world.

The annual base pay (or hourly rate of compensation) for this position ranges from $228,000 to $344,000 . Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. 

AstraZeneca offers an environment where work transcends ordinary boundaries. With a rapidly expanding portfolio, you'll find yourself immersed in a culture that encourages growth, innovation, and connection. Our entrepreneurial spirit combined with global resources allows us to push scientific boundaries while meeting the needs of underserved patients. You'll be supported by exceptional leaders and peers who are committed to making a difference in healthcare.
Ready to make an impact? Apply now to join our team!

Date Posted
23-Oct-2025
Closing Date
29-Oct-2025Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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