Global Development Scientist Director, Late Development Oncology

Location: Barcelona, Spain (3 days/week working from the office)

The Global Development Scientist Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST), working synergistically and cross-functionally in a matrix environment with CPT and GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel.

The Global Development Scientist Director and counterpart Global Development Medical Director collaborate on clinical aspects underpinning a clinical program, sharing responsibility with Clinical Operations for planning and execution, including recruitment and delivery of a clinical study. Accountabilities include clinical support for the development and implementation of late-phase AstraZeneca-sponsored clinical program strategies, providing clinical input into design and implementation of clinical trials, their delivery, clinical data review, interpretation of results, reporting on time, and activities required for worldwide registration of the product (e.g., clinical input to NDA/BLA).

The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and contribute to cross-asset or cross–tumor area working groups depending on experience.

As a key member of the clinical team, this position requires strong collaborative communication skills and the ability to engage with and influence a diverse range of stakeholders within and external to AstraZeneca. The individual operates according to the highest ethical standards, in compliance with internal SOPs, local regulations, laws, and Good Clinical Practice and regulatory requirements.

Depending on experience, the role will mentor less experienced members of the clinical team.

Clinical Development Responsibilities / Accountabilities

• Work cross-functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the study concept document, study protocol, and related documents (e.g., Global ICF, CRF, TFL shells).
• Develop relationships with consultants and key external experts (KEE) and study sites, using these relationships to obtain feedback on protocol design, study training, study execution, and interpretation of study results.
• Ensure relevance and accuracy of the clinical science underpinning the study based on detailed scientific review and consultation.
• Provide clinical and scientific leadership and integrity of protocols and/or components of clinical plans.
• Support or lead interactions with Global Medical Affairs, marketing companies, Commercial, and Regulatory functions in collaboration with GCH/GCPL to ensure cross-functional input into protocols.
• Contribute to technical review of protocols with governance bodies such as DRC and PRC.
• Support health authority interactions as needed.
• Contribute to development of the Medical Oversight Plan (MOP).
• Contribute to study-level safety reviews.
• Contribute to study-level medical monitoring activities.
• Contribute to timely initiation and delivery of clinical trials in close collaboration with Clinical Operations and other CPT/GST members (including supply chain and sample management).
• Serve as a core member of the GST representing Clinical Development.
• Provide clinical input into Feasibility Questionnaires and be consulted on country and site selection.
• Provide clinical and scientific input into the study and ensure quality of clinical data.
• Provide timely responses to investigational study sites for local ICF changes and protocol and EC/IRB questions/requests.
• Contribute to advisory boards to engage site-specific KEEs to ensure robust study designs and recruitment strategies.
• Partner with Clinical Operations (including Program Management, GSTs, SMM, and investigational sites) to proactively flag recruitment risks, propose mitigations, and support timely implementation.
• Engage proactively with MSLs to build strong partnerships with SMMs and KEEs to provide robust feasibility assessments and streamline study execution.
• Contribute to development and delivery of investigator and monitor training (face-to-face or virtual).
• Contribute to review and interpretation of clinical data (HLRs) and development of content for governance committee interactions seeking Go/No-Go decisions.
• Support development of clinical components of regulatory and EC/IRB submission documents where marketing approval is warranted.
• Contribute to development and delivery of the clinical study report.
• Work cross-functionally on launch and branding materials and publications.
• Mentor less experienced staff where appropriate.

Technical Skills

• Drug Development / Clinical Development Planning: Able to plan and organize components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
• Able to drive/contribute to protocol design, writing, and implementation to meet GCP, ICH, and AZ quality standards.
• Solid understanding of methodology in design, conduct, review, interpretation, and presentation of clinical research.
• Able to conduct literature reviews to inform protocols and author background sections on disease or current medical therapy.
• Provide clinical input into options for study design and development of the statistical analysis plan.
• Effectively organize content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents (e.g., CTA, briefing book, BLA/NDA).
• Emerging communication and presentation skills to clearly communicate scientific concepts/data in team settings and formal presentations to leadership committees (e.g., LSPC, DRC, PRC) or external groups (e.g., Investigator Meetings, IDMCs, conference presentations).
• Emerging leadership skills to influence others and drive consensus building.
• Ability to contribute to clinical reports and integrated summary reports.

Typical People Management Responsibility

• Direct/indirect reports: 0–1
• Approximate number of people managed in total (all levels): [Not specified]
• Matrix Manager: Projects/dotted line
• Manager of a team: [Not specified]
• Grandfather (manager of a manager): [Not specified]

Global Remit Operates in:

• Own country
• Another country
• 2 or 3 countries at a minimum of 40% of time
• 4 or more countries at a minimum of 40% of time
• Remit which covers all AstraZeneca countries

Education, Qualifications, Skills and Experience Essential (Minimum Requirements)

• Required Life Sciences degree or equivalent.
• PharmD, PhD in life sciences, or MD preferred; strong preference for oncology experience.
• Industry or academic experience in drug development required.
• Detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.
• General knowledge of medical monitoring; regulatory approval processes in relevant countries; pharmaceutical industry/R&D operations; marketing and commercial fundamentals.
• Ability to grow and maintain a high level of expertise in the oncology therapeutic area.

Date Posted

17-nov-2025

Closing Date

08-dic-2025

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.