Biolog

Do you want to make a difference for millions of patients by applying your expertise in a global company that follows the science and turn ideas into life changing medicines? Join us now to be part of the development of future treatments of Cardiovascular, Renal and Metabolic diseases! We are now recruiting an Associate Director of Clinical Development (ADCD) to the Clinical Operations function of Late Stage Development Cardiovascular, Renal and Metabolic therapy area in BioPharmaceuticals R&D. This role can be based either of AstraZeneca's R&D site in Gaithersburg (US) or Gothenburg (Sweden). What you'll do The role is a core global, the span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported will be in Phase 3 development or on the market, but the program may include studies in all phases of drug development. The ADCD is responsible for oversight of a program of global studies, covering all clinical development deliverables. The role also involves integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The ADCD will provide input & support to the Director of Clinical Development (DCD) in preparation for governance interactions. The ADCD may act as the lead for cross-functional teams in delivery of clinical activities assigned. In the role, the ADCD may provide project leadership & management for cross-functional clinical submission teams in support of regulatory marketing applications and post registration product maintenance phases. You may also manage improvement or change projects within clinical operations or spanning multiple business areas. Your main accountabilities/responsibilities: As a ADCD, you will be leading cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time; managing resource and risk. You will work closely with individual study leaders to provide appropriate oversight of a program of studies on behalf of DCD. You will also provide clinical operations expertise into the project (e.g. country selection, feasibility, operational input into design, external partner management) to support governance interactions and project start-up. Supporting the DCD in providing clinical operations expertise into the development of new business case opportunities for review by governance bodies. Project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications is part of the role and you will manage clinical plans (cost, FTEs and timelines) in business reporting systems. You will be an early adopter for new ways of working and act as ambassadors for change when leading teams. You will lead large or complex deliverables and the process to identify and solve operational issues and drive delivery to plan through internal or external partners. You will act as AZ project interface as escalated from study teams with external (e.g. CRO) partners for externally managed/outsourced studies as appropriate. Leadership and program management of non-drug project work, eg cross functional improvement initiatives, will also be a part of your role and you will contribute as Subject Matter Experts. You are expected to be able to work independently and be comfortable to prioritize the work for yourself and your team to meet business objectives and still have an acceptable work life balance. You will also mentor and support people development. Essential for the role: * University degree, preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred * Strong experience from the pharmaceutical industry/similar large multi national organization. * Proven knowledge of clinical operations, project management tools and processes * Previous experience of clinical development/drug development process in various phases of development and therapy areas * Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development * Ability to mentor, develop and educate staff * Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives * Skilled & experienced in change management * Ability to look for and champion more efficient and effective methods/processes of delivering Clinical Development focusing on key performance metrics around reliability, productivity, cost and quality * Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization * Demonstrated ability to set and manage priorities, resources, performance targets, project initiatives in a regional and local environment * Integrity and high ethical standards Desirable for the role: * Project management certification is desirable * Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory * Regulatory submission experience So, what's next? We welcome your application, no later than October 31st. We will review the applications continuously, so please apply as soon as possible!