Director Medical Study Operations

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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
  

This Role May Be For You If

• Foresight of areas for growth, improvement, refinement, and potential risks
• Ability to communicate and effectively influence sr. 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 lead, motivate, and ensure compliance across the department
  

To be considered for this role you must have a minimum of 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 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) and experience or courses pertaining to clinical research and/or medical affairs functional areas. We are seeking a stellar record of being successful in fast-paced, dynamic environment, self-motivated, works with limited supervision, once acclimated to role and enjoys 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 (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)
$180,400.00 - $300,700.00

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Biotechnology

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