Associate Director Clinical Operations *PC 864

Associate Director Clinical Operations
* PC 864

Job Category: Research & Development

Requisition Number: ASSOC
003594

• Full-Time
• Hybrid

Showing 1 location

Waltham MA
830 Winter St
Waltham, MA 02451, USA

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.

• 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, adjust 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; identify gaps and propose solutions to ensure fit for purpose and compliance.
• Contribute to regulatory filings in the US and internationally.
• Lead by example and mentor 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 interact with senior management on project‑related matters and department best practices.
• May direct a team to achieve departmental/organizational goals.

• 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.
• 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 resolution skills.
• Effective decision making and delegation skills.
  
  Occasional travel required (max 5%). Physical Demands

  The following capabilities are required to perform the essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

  • 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.
  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.

  Salary

  Th…