The Director of Clinical Development (DCD) sits within Clinical Operations and is accountable for leading the Clinical Program Team (CPT), a strategic and operational leadership team whose remit is to maximize the scientific and clinical relevance and value of Biopharmaceuticals R&D led projects, and deliver the assessment of clinical Benefit / Risk and clinical development program to time, cost and quality to the Global Product Team (GPT).
The DCD is responsible for program leadership of clinical development deliverables (scope, quality, budget, time, resource and risk).
The role involves integrating strategy, design, feasibility and operational planning to produce business-focused clinical drug development programs.
Effectively partner with the Global Clinical Leader (GCL) and Global Project Statistician (GPS) to provide clear direction and aligned goals to the CPT members / delivery teams
As leader of the CPT accountable to drive and implement critical initiatives on program level ensuring the CPT is operating as a high functioning team
Responsible / accountable for cross functional leadership e.g. driving cross functional GPT activities
Accountable for efficient and effective program management of all GPT clinical development deliverables, including project strategy, design and delivery of CPT driven program / studies to time, on budget and with quality
Responsible for clinical components of regulatory and related submissions, maintenance support for regulatory interactions and reports and clinical contributions to inspection readiness.
Accountable for oversight of all clinical operations activities within the program and for ensuring provision of clinical operations expertise / input into the program (e.
g. feasibility, country selection, operational input into design, Risk based Quality Management and external partner management)
Drive CPT to contribute appropriate content to support high quality governance interactions
Acts as the initial and program-level AZ operational interface with externally managed / outsourced partners (e.g. CRO / ARO) and collaboration / alliance partners for program planning and delivery
Ensure alignment of the clinical strategy, transfer of product knowledge and champion products that are between early and late stage organizations
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
Responsible for ensuring timely compliance with companywide governance controls (e.g. financial oversight, planning and control, continuous assurance, Clinical Trial Disclosure)
Mentor and support people development within Clinical Operations
Be early adopters for new ways of working and act as ambassadors for change
Education, Qualifications, Skills and Experience
Bachelor of Science / Master of Science degree in related discipline, or equivalent work experience. Advanced degree is preferred
Extensive global drug development leadership or equivalent leadership experience demonstrated in a variety of roles.
Experience across the product life cycle with experience in late stage development and ideally across multiple therapeutic areas
Clinical operations knowledge with strong track record of delivery
Comprehensive knowledge of the clinical and pharmaceutical drug development process
Proven ability to develop programs to meet business goals and to assess business risk versus potential value; ability to understand global business requirements
Significant experience of program management and use of project management techniques in complex projects, including resourcing, financial management and business case development
Proven ability to develop successful collaborations with external partners
Strong strategic influencing skills; ability to influence broadly within and outside the organization
Excellent written and verbal communication skills
Proven teamwork and ability to work collaboratively across a wide range of disciplines
Track record of planning and delivery success
Willingness to travel both domestic and international
Demonstrated ability to drive process improvement and / or functional work
Experience of implementing changes in ways of working that focus on increasing efficiency
Regulatory submission experience
Previous success of working in Japan and China to ensure delivery of global programs to meet business needs
Proven experience in leading teams through change
Experience of and insight into the Clinical environment to be able to drive major improvement programs