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**Vice President, Clinical Operations Strategy and Innovation Lead**

2 months ago

Watertown, Massachusetts, United States Miltenyi Biotec Full time
About the Role

We are seeking a highly experienced and skilled Clinical Operations Leader to join our team at Miltenyi Biotec. As a key member of our Clinical Operations department, you will be responsible for leading the development and implementation of clinical trial strategies, ensuring the successful execution of clinical trials, and providing strategic oversight and guidance to our clinical operations team.

Key Responsibilities
  • Develop and Implement Clinical Trial Strategies: Create, execute, and proactively manage clinical trial processes, establishing performance indicators and applying them to ensure the successful execution of clinical trials to agreed timelines.
  • Lead Clinical Operations Team: Oversee, plan, and implement Quality Checks for clinical projects, providing leadership and direction to ensure the highest standards for compliance with Company SOPs, ICH-GCP guidelines, Regulatory Authority regulations, and patient safety standards.
  • Collaborate with Cross-Functional Teams: Interact and collaborate with other department heads as appropriate, and internationally based colleagues to align on strategic imperatives, ensuring effective integration of clinical operations knowledge and expertise into all applicable Clinical Development activities.
  • Represent Clinical Operations: Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, and other key internal stakeholders, taking charge of clinical operations budget.
  • Mentor and Develop Clinical Operations Staff: Lead and mentor Clinical operations staff to support successful internal training and its implementation, serving as an advocate for professional development of Clinical Operations staff.
  • Develop and Maintain Strong Relationships: Develop and maintain strong relationships with CROs, external experts, and Investigators to ensure effective execution of internal and external clinical projects, supporting, training, guiding, and supervising clinical operations staff on vendors management and sponsor oversight for clinical trials.
  • Coordinate with Data Management/Biostatistics: Coordinate with Data Management/Biostatistics to deliver high-quality data deliverables on time and on budget, collaborating with statisticians, data managers, and data overview, clinical study reports, etc.
  • Support Regulatory Submissions: Support CMO in business operations for clinical development activities, providing support for regulatory submissions, supporting dossier development, and participating in interactions with FDA, EMA, and other regulatory agencies if needed.
Requirements
  • Education and Experience: Bachelor's Degree in Life Sciences, or related, and a minimum of 15 years' experience in the areas of clinical operations development and strategic planning, developing, implementing, and leading early to late-stage clinical trials.
  • Therapeutic Experience: Therapeutic experience in oncology coupled with experience with pivotal, multi-site clinical trials is highly desirable.
  • Global Drug Development Experience: Experience with global drug development and NDA/BLA filing.
  • Clinical Data Management Experience: Experience with clinical data management is a plus.
Skills
  • Leadership and Strategic Thinking: Experience leading a rapidly evolving organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems.
  • Clinical Operations Expertise: Expertise in clinical operations - demonstrated ability to effectively manage projects and people in fast-paced environments.
  • Communication and Presentation Skills: Strong communication and presentation skills, demonstrating strong written and verbal communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff.
  • Regulatory Knowledge: Thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods.
  • Results-Oriented Team Player: Results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues located across the US and internationally.