Job Description

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation \xe2\x80\x93 ultimately providing employees with the opportunity to work across teams, functions and even the globe.Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we\xe2\x80\x99re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.What you\xe2\x80\x99ll doAs Global Development Medical Directors, we are diligent and committed to our patient-centric approach, with a sharp focus on improving clinical outcomes.This individual is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working harmoniously 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 GDMD 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 may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset, cross-tumor working groups depending on the level of experience.This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of partners both within and external to AstraZeneca.Responsibilities include: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 AZ SOPs regarding safetyWork cross functionally within clinical product teams (CPT) to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documentsSignificant contributor to the development of program strategy for assigned compound(s)/programs and work with GPT/CPT members to develop a compelling argument for governance approvalProvide experienced clinical input to influence the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal partners, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements, and meets the strategic program objectives.Participate or lead as needed the review and assessment of new opportunities and ESRs.Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and supervise training.Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warrantedServe as mentor of less experienced staff and may include the direct management of one or more staffEssential for the roleRequired M.D degree or equivalent. Strong preference for individuals with clinical training in oncology.Industry or academic experience in drug development is required with oncology therapeutic experiencePossesses detailed knowledge of Good Clinical Practice (GCP) and other regulations governing clinical research.Possesses general knowledge of 1) medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.Drug Development/Clinical Development Planning: Demonstrates a proven track record to both independently complete, and lead peers in completion in components of sophisticated plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.Desirable for the roleAbility to contribute to, and as needed, lead development of clinical reports and coordinated summary reports for sophisticated projectsMaintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.Strong leadership skills with the ability to influence others and drive consensus buildingShows greater independence in the development of options for study design and development of the statistical analysis planGreat People want to Work with us! Find out why:Are you interested in working at AZ, apply today!AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .Date Posted 19-Apr-2024Closing Date 29-Apr-2024AstraZeneca 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