Director, Clinical Affairs

This is whereyour work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride.

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 crossfunctional collaboration while overseeing CROs, study sites, budgets, and timelines. You will also provide leadership to the clinical affairs team, ensuring highquality 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. This includes but is not limited to:
• 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.
• Research Agreements and Study Budgets - 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.

Clinical Affairs Team Leadership

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.

• 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
• 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

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $208,000- $286,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and 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. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

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