Associate Clinical Operations Director *PC 864

Your Role:

This position is a key leadership role that will provide support and guidance to clinical trial teams whose objectives are to deliver innovative advanced therapy clinical trials consistent with Miltenyi Biomedicine values and goals.

This role will also be responsible for collaborating with internal cross-functional teams, clinical sites, and CRO partners to execute global clinical programs in a safe, ethical, and compliant manner.

Essential Duties and Responsibilities:

• Ensure safe, ethical, and compliant clinical trials as per ICH GCP, federal, international, local, and otherwise applicable regulatory agency requirements.
• Share a broad view of Miltenyi Biomedicine's goals and performance. See beyond personal and functional benefit, champions company and team decisions within trials being conducted in the US and abroad.
• Ensure alignment of individual trial goals, plans, key performance/ risk indicators, management of forecast and study budgets, and trial timelines with departmental and
• company objectives.
• Collaborate with US, EU, and international colleagues, CROs, and investigators to identify risks and formulate effective clinical trial plans. Responsible for forecast and management of individual trial budgets / timelines, as well as CRO management and investigator interactions.
• Execute to plan and as unanticipated risks or challenges arise, adjusts by working with colleagues within Clinical and QA, CROs, and investigators toward resolution
• Work within cross-functional team to develop high quality study deliverables (e.g., Protocols, CRFs, SAPs, CSRs, cell handling manual, etc.)
• Evaluate team and company KPIs, KRIs, existing best practices, and SOPs; identifies gaps and proposes solutions to ensure fit for purpose and compliance.
• Contribute to regulatory filings in the US and internationally.
• Lead by example and mentors other Clinical Operations team members, including employee development through company goal setting, performance management processes.
• Work with leadership to define project staffing plans, talent development, and talent acquisition.
• Regularly interacts with senior management on project-related matters and department best practices.
• May direct a team to achieve departmental/organizational goals.

Requirements:

• Bachelor's Degree - Life Sciences; 10+ years progressive related work experience, at least 5 of which were with a biopharmaceutical (Sponsor) organization.
• Prior experience overseeing CRO selection and contracting processes.
• Must have thorough understanding of GCP and ICH regulations, clinical trial monitoring, and regulatory compliance.
• Prior clinical CRO, trial site, or research experience in advanced therapies also desirable.
• Excellent written and verbal communication.
• Ability to collaborate cross-departmentally and cross-functionally.
• Effective in objective data management know-how, data interpretation and communication as well as expression of abstract ideas to all levels of the organization.
• Strong interpersonal and conflict resolutions skills.
• Effective decision making and delegation skills.

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 walk; use hands and fingers, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to 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 variety of facilities. Each person performing this job must have a home office environment, which is temperature controlled. This job requires the person to be mobile to visit customer sites. Due to the travel requirements, this position may be exposed to natural elements of nature. Used research/clinical equipment may be handled in this job and strict SOPs must be followed, and PPE must be worn.

The hiring range for this position is expected to fall between $129,300-$175,000/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 Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biomedicine, 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.