Director Medical Study Operations

Regeneron Pharmaceuticals • Sleepy Hollow, NY

78d • $180,400 - $300,700

About The Position

The Director, Medical Operations, will oversee several of our External Sponsored Research (ESR) programs including Investigator-Initiated Studies (IIS) and Research Collaboration (RC). Responsibilities will also include people management, maintaining appropriate structure and procedures to support our growth. Additionally, you will ensure timely deliverables and financial management support. As a Director in Medical Operations, a typical day may include the following: Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, and key deliverables, 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 brand and corporate strategy, and ensuring no conflicts with ongoing development plans. Alliance (collaboration partner) Management: Ensuring optimal alignment with both Alliance and internal collaborators for both processes and strategy supporting a therapeutic area or multiple products. Responsible for driving activities forward while communicating potential risks and solutions transparently. Ensure ESR programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to implementing. Program management: budgets, timelines, publications, risk management, compliance: Oversee all aspects of program planning in support of multiple products or a TA, including: life cycle management planning, allocation and movement of program budgets, timelines and program deliverables, risk strategy/mitigation planning, and ensuring annual review of Areas of Interest in alignment with corporate strategy. Ensures compliant, efficient, and effective management and execution of each program's deliverables. Budget tracking, planning, reporting: Oversee all budgeting aspects including annual planning, initial projections for upcoming activities/programs, drug related costs, reforecasts, actuals and accrual information. Oversees budget reporting for the following: program planning, corporate audit, sunshine act, and commercial finance. Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines: Oversee 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, maintaining compliant support of programs. Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness. Recruit and develop direct reports ensuring growth minded goals, and development plans.

Requirements

• Minimum of Bachelor's degree or an advanced degree or equivalent work experience
• 16+ years of 'progressive' industry/relevant professional experience
• Experience in the Biotech/Pharmaceutical industry is mandatory
• 11+ years active work experience in area of clinical research and/or regulatory and/or field-based function in pharmaceutical and/or biotech company(ies)
• Experience or courses pertaining to clinical research and/or medical affairs functional areas
• Stellar record of being successful in fast-paced, dynamic environment
• Self-motivated, works with limited supervision, once acclimated to role
• Enjoys working with different collaborators (clinical, pre-clinical, commercial, external customers)

Nice To Haves

• Foresight of areas for growth, improvement, refinement, and potential risks
• Ability to communicate and effectively influence senior management both internally and externally
• Critical thinking skills with unique problem-solving abilities for new and novel obstacles
• Ability to redirect and create solutions for new regulations or anticipation of updated regulations
• Ability to lead effectively, motivate, and ensure compliance across the department

Responsibilities

• Support of Investigational and/or Commercialized Products, including non-filing post-marketing research activities, timelines, and key deliverables, 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 brand and corporate strategy, and ensuring no conflicts with ongoing development plans
• Alliance (collaboration partner) Management: Ensuring optimal alignment with both Alliance and internal collaborators for both processes and strategy supporting a therapeutic area or multiple products
• Ensure ESR programs are led compliantly, with cross-functional reviews and inputs completed, and senior input as needed prior to implementing
• Program management: budgets, timelines, publications, risk management, compliance
• Budget tracking, planning, reporting: Oversee all budgeting aspects including annual planning, initial projections for upcoming activities/programs, drug related costs, reforecasts, actuals and accrual information
• Drug/material planning, shipping, tracking, expiry, temp excursions, quarantines
• Compliance: ESR Processes, FMV, Safety, Regulatory, Training
• Recruit and develop direct reports ensuring growth minded goals, and development plans

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees at all levels

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees