Senior Director, Translational Sciences Strategy & Quality Lead, Rare Diseases

As a key member of the Translational Sciences Leadership Team you will serve as strategic and operational support to ensure the seamless execution of departmental priorities and initiatives driving operational excellence and facilitating crossfunctional coordination. You will partner with the Translational Sciences Leadership Team to coordinate development of annual objectives define measurable metrics and success criteria and supervise progress tracking and reporting progress towards goals. This role requires a high level of interactive communication negotiation and effective collaboration. This necessitates considerable tact discretion and persuasion to obtain desired outcomes while maintaining ongoing professional relationships. The role is based in New Haven with occasional travel to our Boston location. This is an officebased role with an expectation for a minimum of 4 days per week in office.

Accountabilities

Translational Sciences Leadership Team management:

• Lead Translational Sciences LT and F2F meeting planning including agenda development facilitation and monitoring and tracking actions to ensure organizational alignment.
• Develop and curate executivelevel presentations synthesizing complex information into concise visually compelling formats to facilitate highlevel discussions and decision making.
• Oversee workforce and budget forecasting confirming functional team projections and ensuring alignment with all planning cycles and financial targets. Monitor expenditures identify variances and implement corrective actions as needed.
• Support capacity and resource management by working closely with Strategy and Business Planning and Scientific Planning and Operations to ensure optimal staffing and budget allocation in support of the Rare Diseases portfolio.
• Drive proactive resource planning discussions to assess and address priority gaps through strategic reallocation contractor hiring or permanent staffing solutions.
• Coordinate recruitment and support the onboarding and induction of critical hires.

Portfolio Management and Prioritization

• Responsible for setting leading and facilitating prioritization for the Translational Sciences Department for allocation of budget and resources towards business priorities in line with various planning cycles.
• Accountable for maintaining oversight of Translational Sciences initiatives and process improvements.
• Coordinate Translational Sciences communications including town halls and leadership updates to share key achievements new hires and important events through appropriate channels.
• Manage the development and refinement of the overall operating model to facilitate strong crossteam collaboration.
• Plan and drive the delivery of the portfolio of Translational Sciences initiatives in collaboration with key partners and individual contributions. This may involve as needed leading nondrug scientific strategic quality technical and change management projects and programs.
• Establish and maintain critical metrics to measure operational effectiveness inform strategic decisionmaking and ensure continuous improvement.
• Apply methodologies and tools to translate project vision into practical project plans that ensure impactful solutions in a timely and efficient manner.
• Support business use cases for new initiatives if required.
• Partner with R&D Quality to ensure fitforpurpose riskbased quality standards for bioanalytical and biomarker development and usage in clinical trials.
• Lead an operational quality team within Translational Sciences to ensure internal and external specialty lab compliance with regulatory standards and patient protection regulations while driving the generation of robust reproducible data to support regulatory submissions.
• Oversee compliance of ontime completion of rolebased training for Translational Sciences support development of training plans when necessary and contribute to the development and revision of procedural documents.
• Maintain relationships across functions to ensure Rare Disease biomarker portfolio deliverables are aligned with Research and Clinical Development.

Essential Skills/Experience

• PhD with 10 years of related experience (may include postdoc experience) MS with 15 years and BS with 20 years of related experience in Translational Sciences drug development and/or biomarker development including experience in early phase portfolio management (example: Goals Setting Prioritization).
• Great foundation in GLP and GCP to support bioanalytical and biomarkerdriven strategies from preclinical testing through bioanalytical validation clinical validation and clinical utility. Prior GCLP experience a plus.
• Excellent verbal and written communication skills with a demonstrated ability to engage and present effectively to senior management and business partners.
• Strategic approach capable of translating highlevel objectives into effective operational execution.
• Ability to lead inspire and empower teams to deliver results in a dynamic environment.
• Proven track record of delivering key strategic programs and projects.
• Strong collaborative partnering and interpersonal skills to build positive relationships and influence across different levels and sectors of the organization.
• Proficient at simplifying and optimizing business processes to increase organizational value.
• Experience balancing constant change in a fastpaced environment while managing complex highly interdependent issues.
• Consistently upholds the highest standards of integrity in business decisions regulatory compliance and ethical practices.
• Demonstrated proficiency in organization and project management skills with meticulous attention to detail.
• Broad experience and familiarity with various processes applicable to Translational Sciences including operational quality and general business processes.
• Leadership skills including the ability to solve problems that involve many decision makers build relationships and develop multiple options/recommendations.
• Extensive project management experience and strong strategic influencing skills including negotiation facilitation and conflict resolution skills.

When we put unexpected teams in the same room we ignite bold thinking with the power to inspire lifechanging medicines! Inperson working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of four 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 unique and ambitious world.

Joining Alexion means embracing an opportunity where work isnt ordinary. We are a beacon in the global Biopharmaceutical landscape. Our closeness to patients brings us closer to our work and each other. Combined with our brave pioneering spirit we are truly unique in R&D and healthcare. At Alexion grow and innovate in a business with a rapidly expanding portfolio. Enjoy the vibe entrepreneurial spirit and autonomy of a leading biotech. Youll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team youll meet the needs of some of the most underserved patients in the world. You will be empowered with tailored development programs designed not just for skill enhancement but for fostering a deep understanding of our patients journeys. Youre supported by exceptional leaders ready to lift you in marketing compliance and beyond.

Ready to make a difference Apply now!

Date Posted

07May2025

Closing Date

29May2025Alexion 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 lack thereof sex sexual orientation age ancestry national origin ethnicity citizenship status marital status pregnancy (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 an interactive dialogue with Alexion regarding an accommodation please contact Alexion participates in EVerify.