Director, Study Operations

Job Title: Director, Study Operations

Location: Durham, NC
 

Introduction to role

Are you ready to lead and inspire a team dedicated to delivering life-changing medicines? As the Director of Study Operations, you'll be at the forefront of developing and guiding Study Management personnel to ensure the successful delivery of both drug and non-drug projects. Your leadership will be pivotal in resourcing study teams, embedding consistent practices across locations, and building capabilities within Study Management. You'll empower your direct reports with the skills needed to lead clinical trials effectively and drive the implementation of global strategies in BioPharmaceuticals Clinical Operations. Are you prepared to make a difference?
 

Accountabilities

Line management of Study Management Late staff

• Recruit, Retain & Develop personnel

• Demonstrate AZ values

• Provide skills and capability training to personnel to support their development

• Ensure personnel have been trained and work within compliance of ethics, company policies and standard procedures

• Role model and embed a performance-driven culture and coach staff for optimum performance

• Develop and nurture capabilities of our present and future AZ leaders

• Manage performance including feedback and rewards

• Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building, and issue resolution to facilitate achievement of objectives on time and to appropriate quality

• Timely assignment of capable Study Management resources to meet the clinical study team demands, in collaboration with other members of Study Management Leadership team, and the Capacity Management Team
   

Study Management

• Participate in setting, and responsible for implementing, the vision & strategy for the Study Management, aligned with BioPharmaceuticals Clinical Vision & Strategy

• Contribute to business strategy and streamline processes for drug/non-drug projects or departmental activities

• Lead and support change by encouraging diversity of solutions and implementing process changes consistently across Study Management

• Act as a change Agent, with local and global impact, to ensure adoption of global initiatives

• Promote and encourage innovation and creativity

• Work within Study Management to achieve accurate resource forecasting and develop solutions to efficiently and flexibly resource study teams

• Promote and encourage communication within and across Study

Management and BioPharmaceuticals Clinical

• Ensure quality and compliance to External Regulations and AZ Standards

• Work across the locations to develop global efficient ways-of-working

• Provide expert input into functional and cross-functional global processes

• Foster the sharing of study delivery knowledge, information, and best practice

Essential Skills/Experience

• Bachelor’s degree required, preferably in medical or biological science, or related subject or equivalent qualification or experience.

• 10 or more years of experience in the pharmaceutical industry

• Comprehensive experience of clinical and Drug Development process within a pharmaceutical or clinical background

• Proven leadership and ability to promote motivation and empower others in order to accomplish individual, team, and organizational objectives

• Thorough knowledge of Study Management processes in both local regulation and global environment

• An understanding of the therapeutic areas related to AstraZeneca’s products

• Strong leadership, problem solving, stakeholder management, and conflict resolution skills

• Ability to lead change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business

• Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment

• Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills

Desirable Skills/Experience

• Advanced degree in a scientific discipline

• Line management experience

• Expert reputation within the business and industry

• Extensive knowledge of the latest technical information

• Ability to look for and champion more efficient and effective methods/processes of deliver