Clinical Affairs Manager

$119,076 - $145,537/Yr

Solventum Konsult Ab - Saint Paul, MN

Full-time - Mid Level

Remote - Saint Paul, MN

About the position

As a Clinical Affairs Manager at Solventum, you will play a pivotal role in shaping the future of healthcare by leading the design of research studies that generate clinical evidence to support both new product launches and existing products. Your work will be integral to the development and documentation of long-term clinical strategies for New Product Introduction (NPI) programs. This involves collaborating with various functions to define the clinical evidence requirements necessary to meet business needs for product launch and growth. You will be responsible for ensuring that the evidence generated supports claim generation, design validation, and satisfies regulatory requirements. In this role, you will lead discussions with NPI teams, Product Development labs, and marketing to prioritize clinical evidence needs. You will present these needs for clinical resourcing and study development, ensuring that all aspects of the research proposal are well-defined, including objectives, endpoints, and subject population. Your leadership will extend to supporting business segments by conducting monthly report-out meetings to communicate the status of ongoing clinical studies and to discuss any new or identified clinical evidence needs. Your expertise will not only contribute to the success of product launches but will also enhance the overall quality of healthcare solutions provided by Solventum. You will be working in a collaborative environment with some of the most innovative and diverse minds in the industry, making a significant impact on the lives of patients and healthcare professionals alike.

Responsibilities

• Lead the design of research studies to generate clinical evidence for new product launches and existing products.
• Develop and document long-term clinical strategy for New Product Introduction programs.
• Collaborate with other functions to define clinical evidence requirements for product launch and growth.
• Lead discussions with NPI teams, Product Development lab, or marketing to prioritize clinical evidence needs.
• Present clinical evidence needs for clinical resourcing and study development.
• Work with cross-functional teams to develop on-time research proposals outlining study design, objectives, endpoints, and subject population.
• Support business segments by leading monthly report-out meetings to communicate the status of ongoing clinical studies.

Requirements

• Bachelor's Degree or higher AND three (3) years of recent and relevant clinical research experience in a private, public, government or military environment.
• OR High School Diploma/GED AND ten (10) years of relevant clinical research experience in a private, public, government or military environment.
• Strong strategic thinking to inform business decision making by translating evidence needs and gaps into clinical outcomes.
• Excellent written and verbal communication skills.
• Experience in identifying research needs, establishing research strategy, study trial design, site selection, investigator qualification, protocol, and/or final report writing/editing.
• Demonstrated ability to prioritize and manage multiple projects while adapting to changes in work priorities, strategies, and procedures.
• Ability to collaborate with colleagues to innovate, problem solve, influence, and negotiate as needed.
• Familiarity with regulatory guidelines (FDA, MDR, NMPA) for clinical research.
• Experience reviewing external research protocols with the intention to support financially or with product.

Nice-to-haves

• Experience in clinical research within the healthcare industry.
• Knowledge of advanced statistical methods and data analysis techniques.
• Familiarity with project management tools and methodologies.

Benefits

• Medical, Dental & Vision insurance
• Health Savings Accounts
• Health Care & Dependent Care Flexible Spending Accounts
• Disability Benefits
• Life Insurance
• Voluntary Benefits
• Paid Absences
• Retirement Benefits