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 t