Associate Director, Program Operations Lead - (Non-interventional)

Location
Tarrytown, NY, United States
Posted
Nov 15, 2020
Ref
20549BR
Required Education
Bachelors Degree
Position Type
Full time
As the Program Operations Leader (POL) you'll be responsible for leadership and overall strategic management of one or more complex programs in Clinical Trial Management (CTM). We are looking for a creative problem solver who can provide innovative and flexible operational solutions and options to the cross functional and development teams. We're looking for someone who can also contribute to process improvement initiatives for the larger Global Development organization to support our rapid growth. You will be a valued member of the CTM extended leadership team, interacting with critical stakeholders like senior level management, external vendors, collaboration partners and clinical study personnel. This is an exciting time to join our team and have a direct impact on bringing life-saving treatments to the market.
As a POL, a typical day might include the following:
  • Maintaining an overview of clinical program(s) status and issues and proactively communicating progress, risks, issues or changes that may impact quality, timelines and/or budget; providing clinical program level updates partners as requested
  • Providing input and insight into Clinical Study Concepts (CSC)
  • Reviewing plans and provision of clinical operations expertise during protocol design, feasibility, study start up and conduct phases of studies. Ensuring consistency within the program and development of standard methodologies within CTM
  • Overseeing clinical study budgets and timelines through the lifecycle of the program, communicating changes to therapeutic area operations team as needed
  • Driving decision making and integrating all operational considerations for studies within the program(s) to ensure goals are attainable prior to implementation
  • Serving as a point of escalation for critical issues at the clinical program and study level
  • Providing proactive creation and implementation of risk mitigation strategies
  • Driving strategies for vendor selection and managing the Clinical Research Organization (CRO) and vendor(s) as it relates to program level results and relationship with key CRO (functional and project) and vendor counterparts
  • Representing CTM for a program(s) at review committee meetings as appropriate
  • Participating in CRO governance meetings and Joint Meetings with Collaborative Partners as needed
  • Ensuring inspection readiness throughout the program lifecycle as well as acting as the cross-functional leader for Regulatory Authority Inspections
  • Accounting for resource forecasting and allocation for clinical studies across respective clinical programs
  • Directly supervising Clinical Trial Management staff, including assigning work, performance management, recruitment, mentoring and professional development
This role might be for you if:
You have direct management experience with shown success building and developing outstanding teams
You have the capacity to understand and implement the strategic direction and guidance for respective clinical programs
You can take a proactive and self-disciplined approach to running projects with a developed ability to prioritize to meet established goals
You have a history of effectively leading and negotiating with vendors
You use data to guide your approach to planning, executing and problem solving
You operate with a high degree of cross-functional agility using outstanding influencing and interpersonal skills
You have the innate ability to rally disparate groups to accomplish lofty shared goals

To be considered for this opportunity you must possess a Bachelors' degree with a minimum of 12 years of relevant industry experience, including 8 years within the function. Advanced degrees may be considered in lieu of relevant experience. Extensive global clinical trial operations experience and solid understanding of GCP and ICH is a must. You will also need technical proficiency trial management software and MS applications to be considered.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

#LI-BO1
• Bachelor's Degree required
• Expertise in non-interventional Registry and Collaboration Studies or similar projects/research
• Working knowledge of regulations and requirements for Registry and Collaboration Studies
• Extensive experience in global clinical trial operations
• Strong interpersonal & leadership skills
• Ability to provide strategic direction and guidance for portfolio of studies
• An understanding of relevant industry trends
• Analytical skills with a data driven approach to planning, executing, and problem solving
• Effective communication skills via verbal, written and presentation abilities
• Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
• Ability to influence and negotiate
• Budget management experience
• Ability to build productive teams and collaborations
• Strong project management, cross-functional team leadership and organizational skills
• Demonstrated vendor management experience
• Line management experience with demonstrated mentoring and coaching skills
• A working knowledge of GCP and ICH
• Up to 25% Travel

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.