What are the responsibilities and job description for the Senior Manager, Clinical Study Lead, Inflammation & Immunology position at BioSpace?
Build Our Future Together
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, accountable for the global execution of large and complex clinical trials from study design through close out. In this role, you will lead cross-functional study teams and oversee CROs and vendors, ensuring studies are delivered on time, on budget, and in accordance with ICH/GCP and Regeneron SOPs. You will also supervise Clinical Trial Management staff and drive process improvement initiatives. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
Work model/flexibility: Primarily on-site with hybrid flexibility
Travel percentage: Up to 25%
Discover Your Role
Lead the cross-functional study team as the primary point of contact for assigned studies, with high independence and accountability for timelines, budget, and quality
Provide operational input into protocol development and key study documents, including data management, monitoring, and statistical analysis plans
Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies
Select, contract, and oversee CROs and third-party vendors to ensure delivery against the scope of work
Manage study budgets and timelines, identify risks, and escalate issues with clear mitigation plans
Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit and inspection ready
Manage study close-out activities and contribute to clinical study reports and lessons learned
Supervise, coach, and develop Clinical Trial Management staff while driving innovation and process improvement across the department
This Role Requires
Bachelors degree and 8 years of relevant clinical trial experience
Extensive experience in global clinical trial operations, with knowledge of ICH/GCP and regulatory guidelines
Line management experience and the ability to build, lead, and develop productive study teams
Strong budget management, vendor management, and negotiation skills
Exceptional interpersonal, communication, and influencing skills across a wide range of stakeholders
Preferred: Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and MS applications
Preferred: Awareness of relevant industry trends and experience driving process improvement
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Clinical Study Lead to join our Clinical Trial Management team, accountable for the global execution of large and complex clinical trials from study design through close out. In this role, you will lead cross-functional study teams and oversee CROs and vendors, ensuring studies are delivered on time, on budget, and in accordance with ICH/GCP and Regeneron SOPs. You will also supervise Clinical Trial Management staff and drive process improvement initiatives. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & Where
Location: Tarrytown, NY, Warren, NJ, Cambridge, MA
Work model/flexibility: Primarily on-site with hybrid flexibility
Travel percentage: Up to 25%
Discover Your Role
Lead the cross-functional study team as the primary point of contact for assigned studies, with high independence and accountability for timelines, budget, and quality
Provide operational input into protocol development and key study documents, including data management, monitoring, and statistical analysis plans
Lead feasibility assessments, site evaluation and selection, investigator meetings, and patient recruitment and retention strategies
Select, contract, and oversee CROs and third-party vendors to ensure delivery against the scope of work
Manage study budgets and timelines, identify risks, and escalate issues with clear mitigation plans
Oversee data quality, protocol deviations, and study systems such as CTMS and TMF to keep studies audit and inspection ready
Manage study close-out activities and contribute to clinical study reports and lessons learned
Supervise, coach, and develop Clinical Trial Management staff while driving innovation and process improvement across the department
This Role Requires
Bachelors degree and 8 years of relevant clinical trial experience
Extensive experience in global clinical trial operations, with knowledge of ICH/GCP and regulatory guidelines
Line management experience and the ability to build, lead, and develop productive study teams
Strong budget management, vendor management, and negotiation skills
Exceptional interpersonal, communication, and influencing skills across a wide range of stakeholders
Preferred: Advanced proficiency in trial management systems (CTMS, EDC, IVRS/IWRS) and MS applications
Preferred: Awareness of relevant industry trends and experience driving process improvement
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00
Salary : $150,500 - $245,500