Director, Clinical Affairs

Baxter International Inc.•Skaneateles, NY

2d•$208,000 - $286,000•Onsite

About The Position

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.

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
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Responsibilities

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.
Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project.
Prepare timelines and budgets for the clinical program.
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.
If services of a Contract Resource Organization (CRO) or Central Laboratory are used, this position will lead the process to select the CRO/Central Lab and establish the contract.
This role involves managing 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, e.g. screening, enrollment, study completion, (serious) adverse events, budgets and forecasts, achievements.
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, directly or through other resources, including accurate completion of critical documents, disposition of study product and preparation of study sites for regulatory authority audits.
Prepare/coordinate final reports.
Prepare annual safety reports.
Formulate clinical monitoring plans within bounds of Clinical SOPs and Health Authority regulations.

Benefits

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
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
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits