Associate Director, Clinical Development
Building on a 50-year heritage in respiratory care, our ambition is to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by driving earlier, biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. Underpinning chronic lung diseases is an altered immune system. We are following the science of common pathways and underlying disease drivers from respiratory disease into immunology-driven disease areas. The disease areas we’re targeting include rheumatology (including type 1 interferon-driven diseases such as lupus), dermatology, gastroenterology and systemic eosinophilic-driven diseases. Our ambition is to achieve disease modification and durable remission in these diseases for millions of patients worldwide.
The Associate Director of Clinical Development (ADCD) is a core global role within the Clinical Operations function of Late Stage R&D (BioPharmaceuticals). 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 (including aspects of quality, budget, time, resource and risk). 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 (e.g. indication specific sub-teams, Investigator Brochure production, DSUR etc)
Additionally, 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. The ADCD may manage improvement or change projects within clinical operations or spanning multiple business areas.
- 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
- Work closely with individual study leaders to provide appropriate oversight of a program of studies on behalf of director clinical development (DCD)
- Provides 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.
- Support the DCD in providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost, timelines, feasibility, risk)
- Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)
- On behalf of Clinical Project Team, manage clinical plans (cost, FTEs and timelines) in business reporting system, such as PLANIT
- Be early adopters for new ways of working and act as ambassadors for change when leading teams
- Identifies and resolves issues within the clinical project ensuring the escalation of the issue to the appropriate individual/functional/governance group for resolution
- Lead large or complex deliverables (i.e. indication) and the process to identify and solve operational issues and drive delivery to plan through internal or external partners (Alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations).
- Act as AZ project interface as escalated from study teams with external (e.g. CRO) partners for externally managed/outsourced studies as appropriate
- Responsible for leadership and program management of non-drug project work as assigned, eg cross functional improvement initiatives
- Contribute to functional and cross-functional initiatives as Subject Matter Experts
- Mentor and support people development as appropriate.
- Bachelor's Degree, preferably in medical or biological sciences or discipline associated with clinical research, as well as at least 10 years’ experience from within the pharmaceutical industry or similar organization.
- Advanced degree is preferred but not required.
- Proven knowledge of clinical operations, project management tools and processes
- Proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Proven ability to learn by working in multiple phases, TAs and/or different development situations.
- Experience from leading clinical projects and deliverables or similar expertise from other areas of drug development (such as pharmaceutical development).
- Ability to mentor, develop and educate staff
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational 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 and project initiatives in a regional and local environment
- Integrity and high ethical standards
- Project management certification is desirable but not mandatory.
- Knowledge of process improvement methodology such as Lean Sigma/Change Management is desirable but not mandatory
- Regulatory submission experience
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.