Director, Clinical Trial Management Early Development

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

The Director, Early Development Clinical Trial Management, is responsible for driving operational activities related to the conduct of clinical research projects in order to ensure deliverables and program objectives for Early Clinical Development. The Director collaborates with therapeutic area medical heads on medical and scientific aspects of the program/study, interacts at a visible level with internal senior level management, external vendors, collaboration partners and clinical study personnel to ensure compliance with protocol and clinical research project objectives. The Director is responsible for managing trial management staff, while staying aware of the cyclical nature of clinical research to proactively and effectively mitigate risk across studies.

  • Delivers high quality program deliverables on time and within budget
  • Performs job duties with minimal guidance
  • Manages, tracks, and troubleshoots a series of related trials within a single program
  • Identifies program risks; proactively creates and implements mitigation strategies
  • Leverages operational expertise and communicates operational needs effectively to ensure goals are met
  • Drives decision-making and integrates all operational facets for studies within a program to ensure goals are attainable prior to implementation.
  • Develops work plans, establishes clinical research objectives, assigns tasks appropriately (aligns skill sets with assignments.)
  • Maintains schedules (timelines) for overseeing assigned clinical research studies and drives decision making to ensure adherence to timelines
  • Provides guidance to Clinical Team through setting clinical research goals aligned with department policies and standards
  • Identifies and recommends changes to practices and policies
  • Directs activities of resources, both internal and outside contractors/vendors, with similar technical or functional responsibilities
  • Recommends additional resources based on needs to meet goals and milestones
  • Acts as a point of escalation for internal and external team members
  • Interacts with Data Management to ensure data collection are accurate, data queries are resolved in a timely manner, statistical analysis plan is developed, and data is transferred to Regeneron as needed
  • Interacts with CTMs and CRAs to ensure sites are being monitored appropriately, data is collected in a timely manner, and study is progressing properly
  • Plays a key role in outsourcing plans for clinical programs and ensures outsourced services are provided according to the study needs and within the budget
  • Interfaces with senior management to report on project and program milestones and to present project needs
  • Communicates operational aspects of studies in each project throughout the organization
  • Contributes to clinical development planning and life cycle timelines
  • Assists in preparing scenarios for creative solutions to hurdles
  • Acts as the point person for information on status of different projects in program
  • Attends appropriate development and management meetings
  • Provides timely and accurate information to Program Management for program level tracking
  • May have full budgetary responsibilities
  • Ensures review, presentation and approval of initial budget; and communicates changes to management as appropriate
  • Ensures adherence to program budgets
  • Assignments are given in the form of objectives with little or no process defined
  • Develops and provides challenging yet appropriate assignments and communicates progress toward development goals
  • Leads, guides and mentors CTM staff
  • Has a direct supervisory responsibility for CTM staff. Line management responsibilities including work assignments, performance management, professional development, recruiting, ongoing training, and study support/oversight.
Skills/Knowledge Required?? Global Phase I subject and patient trials & safety reporting experience?? Understanding of clinical research development process from program planning to regulatory submission?? Able to quickly develop a working scientific knowledge of different therapeutic areas?? Ability to manage complex operations and projects under accelerated timelines?? Strong leadership skills; ?? Must be able to effectively communicate to all levels of the organization, including senior management?? Analytical problem solving experience?? Must be able to develop and present varied and unique ideas ?? Effective influence and negotiation skills?? Proven Management skills?? Financial acumen in creating and managing clinical program budget?? Ability to build successful collaborations with internal and external partners?? Must possess strong communication skills; verbal, written, and presentation ?? Must have broad knowledge and cross-functional understanding of clinical trial methodology?? Working knowledge of GCP and ICH
Minimum education requirements: Bachelors degree plus 8-10 years of relevant industry experience or fifteen (15) years of relevant industry experience in-lieu of degree. Depending upon prior related work experience, additional training within clinical trial management may be required.

This position may require frequent travel by air, rail, and automobile. External work environment may include physicians offices and hospitals where exposure to pathogens is greater than internal environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Travel up to approximately 25% (including but not limited to travel to field sites, and investigator meetings, conferences).

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.