Associate Director Clinical Operations *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. 
• Occasional travel required (max 5%)

Physical Demands:

• Ability to organize/coordinate
• Comprehend and follow instructions
  Direct, control and plan solve
• Independently make quick decisions to complex issues
  Problem Solve
• Analyze/Interpret data and information
  Perform with frequent interruptions
• Make decisions using sound judgment
• Good eye/hand coordination
  Use keyboard/computer/phone
• Visual Acuity

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 a hybrid, office-based position (i.e. 2 days in office, 3 days remote from home). Each person performing this job must have a home office environment and have regular and predictable attendance