Director Medical Operations, Externally Sponsored Research Collaborations

Role Summary

The Director of Medical Operations will manage our Externally Sponsored Research (ESR) Collaboration program, lead a growth-focused team, and ensure timely deliverables and financial management support. Responsibilities include establishing structure and procedures to support expansion and ensuring program compliance. This position is on-site at the Sleepy Hollow, NY office four days per week; remote work is not offered.

Responsibilities

• Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, results, budgets, forecasting, disclosures, and compliance.
• Support of Late-Stage Molecules and launch readiness activities.
• Support of Early Phases molecules, post-IND filing, ensure non-clinical and non-drug studies are reviewed in line with our strategy.
• Develop a team ensuring growth-minded goals, and development plans.
• Ensuring efficient alignment with both Alliance and internal partners.
• Ensure External Sponsored Research (ESR) programs are led compliantly.
• Program planning, allocation and movement of program budgets, timelines and program results, risk strategy/mitigation planning, and ensuring annual review of Areas of Interest.
• Supervise all budgeting aspects including annual planning, initial projections for upcoming activities/programs, drug related costs, reforecasts, actuals, and accrual information.
• Coordinate appropriate drug/material planning including timing of drug and labeling campaigns, expiry events and potential impact, and ensuring compliance for shipments, temp excursions, and quarantines.
• Compliance: ESR Processes, FMV, Safety, Regulatory, Training.
• Adheres to and ensures team adherence to all applicable SOPs, working guidance, workflows, required reporting, and maintaining support of programs. Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness.

Qualifications

• 11+ years active work experience in clinical research, regulatory or field-based function in the pharmaceutical industry.
• Experience in Medical Study Operations is required.
• Experience leading a team of 2+ ensuring goals are achieved.
• Ability to redirect and create solutions for new regulations or anticipation of updated regulations.
• A science background ideally in the therapeutic areas of oncology is preferred.
• Support medical-focused Externally Sponsored Research, Investigator Initiated Studies and/or Research Collaborations.
• Want to have an impact on patient lives.
• Can demonstrate a track record of being successful in fast-paced, dynamic environment.
• Enjoy influencing management both internally and externally.

Education

• Bachelor's degree required.

Skills

• Leadership and people management
• Cross-functional collaboration and alignment with Alliance and internal partners
• Program budgeting and financial management
• Regulatory compliance, safety, and training
• SOP development, working practices, and audit readiness
• External Sponsored Research program management
• Strategic planning and risk mitigation

Additional Requirements

• On-site presence required at Sleepy Hollow, NY office (4 days/week). Remote work is not offered.