Director, Clinical Data Strategy

When we put unexpected teams in the same room we fuel aggressive thinking with the power to encourage life-changing -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and aggressive world.

Introduction to role:

As the Director of Clinical Data Strategy you will craft and complete the strategy governance and value realization of clinical information. You will focus on our rare programs and projects. Your leadership will ensure that data management and strategy capabilities are aligned with business delivery driving quality timeliness and impactful outcomes. Collaborating across DRS R&D and enterprise functions you will align rCDI R&D data strategy external data strategy data sharing and reuse data governance and data asset value generation to portfolio priorities and regulatory standards. Are you ready to supply to the vision and success of rCDI and the broader Clinical Data Strategy function

Accountabilities:

• Align clinical data strategy priorities to therapy-area and study-level objectives for timely delivery of data for analyses submissions and evidence generation.

• Define and implement the rCDI clinical data strategy across programs including standards adoption and integration of internal and external data sources.

• Establish principles controls and supervising for responsible use of AI/ML in clinical data activities.

• Ensure high-quality compliant data management practices with proactive oversight and continuous improvement.

• Partner with R&D data leaders to harmonize standards and frameworks that accelerate study start-up and data delivery.

• Build and govern the acquisition onboarding and use of external data.

• Establish policies for compliant data sharing and efficient reuse across programs.

• Support governance mechanisms ensuring data is fit-for-purpose secure FAIR-aligned and compliant.

• Define use cases and performance measures to quantify data asset value; champion analytics for actionable insights.

• Facilitate internal information sharing to promote learning and guidelines.

• Lead systems improvements technology adoption and author/review SOPs and training materials.

• Supervise key performance indicators to demonstrate strategic impact.

• Support or lead senior leadership initiatives to demonstrate sophisticated technologies and modern data practices.

• Stay informed on industry trends regulatory requirements data standards and emergent tools.

Essential Skills/Experience:

• 10 years in clinical information management and/or clinical data strategy with a record of driving sophisticated cross-functional initiatives and measurable outcomes.

• Deep understanding of clinical data oversight and drug development processes regulatory submissions data governance data reuse and application of FAIR principles in drug development and research.

• Ability to address sophisticated abstract problems make sound decisions and lead cross-functional initiatives with attention to detail and proactive drive.

• Highly effective written and verbal communication skills to influence and collaborate at all levels within and outside the company.

• Ability to define and lead improvement innovation projects and interact with collaborators from within the organization as well as from outside at senior levels of management.

• Ability to mentor train and lead teams in projects.

• Responsiveness to industry and business needs and adopting peers review.

• Demonstrates strong cross-functional leadership skills.

• Ability to handle and operate comfortably in a professional environment that can be volatile uncertain sophisticated and ambiguous.

• The duties of this role are generally conducted in an office environment. As is typical of an office-based role employees must be able with or without an accommodation to use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and non-linear thought analysis and dialogue; collaborate with people; maintain general availability during standard business hours.

Desirable Skills/Experience:

• A BSc or equivalent experience masters degree or PhD in a related science field.

• Experience in data management data governance external data FAIR Data Principles Implementation and metadata management data cataloging and data product management.

• Experience in leading teams and projects for multiple sophisticated projects ensuring fit for purpose quality and delivery of business value.

• Previous experience in a role that involved developing and driving functional strategies.

• Good understanding of molecule and disease area strategies drug development and research healthcare environments as well as strong scientific and technical data expertise.

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Ready to lead and encourage Apply now and take the first step towards an exciting career at Alexion AstraZeneca Rare Disease.

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Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment training compensation promotion and other terms and conditions of employment based on race color religion creed or lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (including childbirth breastfeeding or related medical conditions) parental status (including adoption or surrogacy) military status protected veteran status disability medical condition gender identity or expression genetic information mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in E-Verify.