Director Medical Study Operations

Overview

The Director, Medical Study 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.

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. 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 programs 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

Qualifications

To be considered for this role you must have a minimum of a Bachelor’s degree or an advanced degree or equivalent work experience. Additionally, we need 16+ years of progressive industry/relevant professional experience. Experience in the Biotech/Pharmaceutical field is mandatory. 11+ years active work experience in the area of clinical research and/or regulatory and/or field-based function in pharmaceutical and/or biotech company(ies) and experience or courses pertaining to clinical research and/or medical affairs functional areas. We are seeking a stellar record of success in a fast-paced, dynamic environment, self-motivated, able to work with limited supervision, and comfortable working with different collaborators (clinical, pre-clinical, commercial, external customers).

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include health and wellness programs, equity awards, annual bonuses, and paid time off for eligible employees at all levels.

Salary Range (annually) : $180,400.00 - $300,700.00

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. Reasonable accommodation is provided to qualified applicants with known disabilities or chronic illnesses where it does not impose undue hardship on the operation of the business.

Note: Background checks may form part of the recruitment process and will be conducted in accordance with applicable laws.