Director Study Management
About The Position
The Director Study Management (DSM) is responsible for leading, developing, supporting, and providing direction to Study Management and Operations (SMO) personnel for project, TA/scientific/technical, and operational related issues to enable delivery of drug projects and non-drug projects. The DSM is accountable for resourcing SMO members on study teams to support delivery of clinical programs in R&D. The role holder will also be responsible for embedding consistent ways of working across Hubs and building SMO capabilities. The DSM will ensure that direct reports are equipped with the right skills and capabilities to optimally lead and deliver clinical trials. Take ownership and act as a change agent to drive consistent implementation of globally agreed Clinical Operations and Clinical Development strategies including processes and technology related to the delivery of studies.
Requirements
- 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 Oncology/Hematology TA.
Nice To Haves
- Advanced degree in a scientific subject area.
- 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 delivering quality clinical trials with reduced budget and in less time.
Responsibilities
- Line management of SMO staff
- Recruit, Retain & Develop SMO personnel.
- Demonstrate AZ values.
- Facilitate skills and capability training to SMO 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 feed-forward and rewards.
- Provide expertise and direction to support direct reports with proactive problem/risk
- Maintain dialogue with Senior DSM and Snr Global Clinical Operations Program Director to anticipate project requirements and mitigate risks to project delivery.
- Allocate appropriately skilled SMO personnel to study delivery teams to ensure delivery of clinical studies to time, budget and quality standards in accordance with clinical performance targets.
- Ensure staff understand global project priorities and specific project challenges: support staff/team to achieve project turning points and study results.
- To work across departments to support the delivery of projects and organizational improvements.
- Participate in setting, and responsible for implementing, the vision & strategy for the SMO Hub, aligned with Clinical Operations and Hematology’s 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 SMO.
- Act as a change Agent, with local and global impact, to ensure adoption of Global initiatives.
- Promote and encourage innovation and creativity.
- Work with Leadership team and Global Study Leads to achieve accurate resource forecasting and develop solutions to efficiently and flexibly resource study teams.
- Promote and encourage communication within and across Hubs and between BioPharma and Oncology SMO.
- Ensure quality and compliance to External Regulations and AZ Standards.
- Work across the Hubs to develop global efficient ways-of-working.
- Provide expert input into functional and cross-functional global processes.
- Provide leadership in local Hub.
- Foster the sharing of study delivery knowledge, information, and best practice on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues.
Benefits
- Annual base salary for this position ranges from 151,884.00 to 199,347.75.
- Annual Variable Pay Bonus/Short Term Incentive opportunity
- Eligibility to participate in our equity-based long-term incentive program (if applicable to role).
- Competitive Flex Benefits & Retirement Savings Program
- 4 weeks’ paid vacation
- Annual Personal Days
- Contract Benefits Program (for Fixed Term Contract/Temporary positions)
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What This Job Offers
Job Type
Full-time
Career Level
Director
