Assoc Director Program Operations Leader- Oncology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, New York
- Start date
- Sep 23, 2022
View more
- Discipline
- Manufacturing & Production, Operations, Science/R&D, Oncology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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 give 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
Responsible for 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 handling 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
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 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 social skills
You have the highly developed 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.
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 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. 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.
Development Operations - #GDDOPMJobs
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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