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Baxter Logo Baxter · IT - Administration

Director, Clinical Affairs

United States, Skaneateles Falls Employment contract 208000.00 - 286000.00 USD / Year · Job Posted June 09, 2026
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Job Description

In this role, you will lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption. You will drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines. You will also provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio

Job Responsibility

  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies and project plan
  • Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project
  • Facilitate preparation of protocols including study design, case report forms, study procedures
  • Develop and complete enrollment feasibility evaluations based on protocol synopsis
  • Draft informed consents based on study and regulatory requirements
  • Prepare research agreements and negotiate study budgets with sites
  • Lead third party CROs and Contractor relationships
  • Coordinate with Medical Affairs to identify clinical investigators and assess suitability of study sites
  • Recognize and maintain strong business relationships with key opinion leaders
  • Lead team members, contractors, and deliver the following directly or by leading others
  • Work with Supply Team to order clinical supplies and ensure logistics plans are in place prior to study start
  • Train study staff on product usage, data collection and specific procedures
  • Plan and conduct investigator meetings
  • Perform Study initiation visits directly
  • Manage clinical study monitoring resources for protocol and regulatory compliance including adverse event reporting and follow-up
  • Manage the day-to-day oversight of the CRO personnel plus the project budget, deliverables, and timeline/achievements
  • Develop and maintain tracking systems as needed for study management
  • Ensure the safety monitoring plan/safety tables have been agreed to by Medial Monitor and Vigilance/Surveillance functions are appropriate
  • Collaborate with data management to establish a clinical data management plan for each project
  • Perform study closeout procedures
  • Prepare/coordinate final reports
  • Prepare annual safety reports
  • Formulate clinical monitoring plans within bounds of Clinical SOPs and Health Authority regulations

Requirements

  • BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
  • Possesses expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports
  • High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Able to monitor performance of team in maintaining system updates to allow for senior management reports
  • Applies current applications/systems to compile information for presentation or distribution
  • Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
  • Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
  • Expertise in project management practices
  • Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
  • Exceptional organizational and team leadership skills

What we offer

  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP)
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
  • Childcare benefits
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Director, Clinical Affairs

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Location
United States , Skaneateles Falls
Salary
Salary:
208000.00 - 286000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
  • Possesses expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Able to monitor performance of team in maintaining system updates to allow for senior management reports
  • Applies current applications/systems to compile information for presentation or distribution
  • Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
  • Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Job Responsibility
Job Responsibility
  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
  • Lead team members, contractors, and deliver the following directly or by leading others
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Fulltime
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Director, Clinical Affairs

Location
Location
United States , Skaneateles Falls
Salary
Salary:
208000.00 - 286000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation
  • Expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports
  • High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Able to monitor performance of team in maintaining system updates to allow for senior management reports
  • Applies current applications/systems to compile information for presentation or distribution
  • Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
Job Responsibility
Job Responsibility
  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies and project plan
  • Partner with Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan
  • Facilitate preparation of protocols including study design, case report forms, study procedures
What we offer
What we offer
  • Medical and dental coverage start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP)
  • 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service
  • Family and medical leaves of absence
  • Paid parental leave
  • Commuting benefits
  • Fulltime
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Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...
Location
Location
United States , Skaneateles Falls
Salary
Salary:
208000.00 - 286000.00 USD / Year
https://www.baxter.com/ Logo
Baxter
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
  • Possesses expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
  • Expertise in project management practices
  • Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
  • Exceptional organizational and team leadership skills
Job Responsibility
Job Responsibility
  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
  • Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
  • Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
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Director, Clinical Affairs

In this role, you will lead the development and execution of clinical strategies...
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Expiration Date
Until further notice
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Requirements
  • Minimum: BA/BS in scientific discipline with minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry
  • medical device preferred)
  • Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements, as applicable to a study (or the requirements within countries in which a study is conducted)
  • Well-established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
  • Possesses expert knowledge of research objectives, protocol design, and data collection standards
  • Experience reviewing monitoring reports. High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
  • Able to monitor performance of team in maintaining system updates to allow for senior management reports
  • Applies current applications/systems to compile information for presentation or distribution
  • Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
  • Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
Job Responsibility
Job Responsibility
  • Lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
  • Drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
  • Provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio
  • Clinical Strategy Development: Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research
  • Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy
  • Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption
  • Conduct Clinical Research: Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials
  • Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance
  • Clinical Plan - Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program
  • Clinical Trial Protocols - Facilitate preparation of protocols including study design, case report forms, study procedures
What we offer
What we offer
  • Medical and dental coverage that start on day one
  • Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
  • Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
  • 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
  • Flexible Spending Accounts
  • Educational assistance programs
  • Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
  • Commuting benefits
  • Employee Discount Program
  • Employee Assistance Program (EAP)
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beamtx.com Logo
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Until further notice
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Requirements
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