Global Development Medical Director, Cell Therapy Oncology

About this role

The Global Development Medical Director is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working collaboratively and cross functionally (in a matrix environment) with other CPT, GST and GPT members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Global Development Medical Director and counterpart Global Development Scientist work collaboratively in the clinical aspects underpinning a product! Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical program strategies, including providing clinical input into design & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to (s)NDA/(s)BLA). The Global Development Medical Director plays a critical role in the medical monitoring of a clinical study ensuring safety to patients. They share responsibility with Clinical Operations team members in the planning, execution and closure of clinical study. The Global Development Medical Director is responsible for the ensuring the risk-benefit of a clinical study, ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance FDA, EMEA, ICH and GCP guidelines as well as SOPs regarding safety. The Global Development Medical Director may also provide expert input or lead functional process improvement initiatives and provide expert contributions to cross asset, cross tumor working groups or cross Therapy Areas, depending on the level of experience. As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of collaborators both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements. Depending upon experience level, the role will mentor the development of less experienced members of the clinical team.

Responsibilities/Accountabilities • Responsible for evaluating the risk-benefit of a clinical study. Ensure all clinical studies follow rigorous ethical and safety principles. They must follow FDA, EMEA, ICH, and GCP guidelines, as well as SOPs related to safety. • Work with clinical product teams (CPT) to develop the study concept document, protocol, and related documents. • Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, and interpretation of study results, and inform recruitment strategies. • Responsible for the relevance and accuracy of clinical science underpinning clinical study based on detailed scientific review and consultation. • Accountable for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans (including, but not limited to, the ICF, CRF, TFL Shells, and Safety Reports). • Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols. • Contributes to technical review of protocols with governance bodies such as DRC and PRC. • Support Health authority interactions as needed. • Contribute to the development of Medical Oversight Plan (MOP), study level safety reviews, and study-level medical monitoring activities • Core member of the GST representing Clinical Development. • Clinical input into Feasibility Questionnaires and consulted on country and site selection • Assure oversight of collected data, monitoring safety and efficacy within a study. • Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests • Proactively engage 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 and the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions. • Support the development of clinical components of regulatory submission documents for instances where marketing approval is warranted. • Development and delivery of the clinical study report • Work cross functionally in the preparation of launch & branding materials and publications. • Where appropriate, serve as a mentor of less experienced staff.

Technical Skills • Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution. • Ability to drive/contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards. • Demonstrates solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research. • Can conduct literature reviews to inform protocols, and author background sections on the disease or current medical therapy. • To provide clinical input into options for the study design and development of the statistical analysis plan. • To effectively organizes content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents • (i.e. CTA, briefing book, BLA/NDA) • Ability to prepare and present clinical data and/or selected training sessions to internal/external groups. • Ability to contribute to clinical reports and integrated summary reports. • Emerging communication & pre

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