Clinical Affairs Specialist *PC 1610

Your Role:

This position is primarily responsible for managing projects and programs that support the development of Phase I cell therapies with our academic partners. This role will also be responsible for supporting the implementation of projects to PMO global standards, Miltenyi business processes, strategic initiatives, and best practices to meet project goals. Support the leadership team in the development of project alignment, with the portfolio, to business strategy, functional constraints, and resource proficiency. The role applies professional expertise and company policies to resolve issues, determine appropriate actions, and refine processes as needed.

Essential Duties and Responsibilities:

• Aid in the execution of the Phase I clinical trials from protocol design to the final clinical study report.
• Execute high quality, integrated cross-functional plans for the project/clinical trial.
• Coordinate the activities of functional groups that comprise the clinical department team for the product including, but not limited to clinical monitoring, data management, statistics, medical writing, medical monitoring, and safety to insure proper conduct and timely completion of all projects.
• Apply best practices in the development, initiation, planning, execution, control and closing of projects. Manage resource shipments to clinical trial sites
• Cross-functional planning throughout Miltenyi teams to ensure site readiness, including data review and working with local teams to arrange training.
• Troubleshoot technical difficulties at the clinical trial sites and leverage other expertise within the Miltenyi team
• Manage quarterly meetings with and collect data from the clinical trial sites
• Engage multiple Miltenyi groups, including additional R&D teams, Marketing, Regulatory, and Sales, to leverage the resources from the clinical trials to further grow the Miltenyi pipeline and support future sales efforts
• Ensure project documents are complete, current, and stored appropriately.
• Create a positive environment by working collaboratively
• Work with the team or project managers, program manager, and PMO to develop and maintain project KPI's and dashboards.

Requirements:

• B.S. in a science-related discipline, e.g. biology, chemistry, biotechnology, biochemistry, molecular biology, or a similar discipline; 5+ years' experience in a similar role. Cell therapy experience preferred.
• Exposure to project management techniques.

Knowledge / Skills / Abilities:

• Must be familiar with a wide range of clinical research and project management areas, including maintenance of complex schedules, document management, internal/external communications, and regulatory frameworks.
• Strong written and verbal communication skills.
• Ability to problem-solve and think critically.
• Understanding of the pharmaceutical and biotechnology industry.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to sit and stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment. Due to the travel requirements, this position may be exposed to natural elements of nature.

The hiring range for this position is expected to fall between $109,417 - $128,702/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. For over 30 years, we have played a pivotal role in the design, development, manufacture, and integration of products for sample preparation, cell separation, cell analysis, imaging, and cell culture needs. These developments have led to cutting-edge cell and gene therapies - transformative methods that mobilize the body's own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow.