New Haven, Connecticut, USA
3 days ago
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 cross-functional 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 office-based 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 executive-level presentations, synthesizing complex information into concise, visually compelling formats to facilitate high-level 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 cross-team 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 non-drug scientific, strategic, quality, technical, and change management projects and programs.Establish and maintain critical metrics to measure operational effectiveness, inform strategic decision-making, 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 fit-for-purpose, risk-based 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 on-time completion of role-based 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

BS/MS/PhD degree and 10 years+ of industry 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 biomarker-driven 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 high-level 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 fast-paced 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 life-changing medicines! In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're 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 isn’t 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. You’ll join an energizing culture where people build connections to explore new ideas. As an important member of our commercial team, you'll meet the needs of some of the most under-served 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 patient's journeys. You’re supported by exceptional leaders ready to lift you in marketing, compliance, and beyond.

Ready to make a difference? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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