Are you ready to partake in the personalized medicine revolution? Miltenyi Biomedicine is a new division of the Miltenyi Biotec family focused on bringing customized cancer treatments and regenerative therapies to patients worldwide. Miltenyi Biomedicine serves an essential role in the Miltenyi Group, bridging the crucial divide from laboratory bench to patient bedside, ensuring that our innovations deliver direct benefits to those contending with some of today's most challenging diseases. Our clinical research and development team is dedicated to tailoring cell and gene therapies to individual patients, specifically working on treatments for hematological cancers using chimeric antigen receptor (CAR) T cell technology. The group is also researching regenerative therapies for Alzheimer's disease, Parkinson's disease, and diabetes in the elderly.
Vice President, Clinical Operations Strategy and InnovationWaltham, MAYour Tasks:
This position will provide leadership, strategic oversight, and guidance of Biomedicine Clinical Operations to ensure quality, timeline, resources and budget goals are met.
Essential Duties and Responsibilities:
- Create, execute, and proactively manage clinical trial processes. Establish performance indicators and apply to ensure the successful execution of clinical trials to agreed timelines. Support establishment of systems necessary to perform clinical activities up to and above the industry standards. Encourages and implements innovative approaches to execute clinical trials.
- Ensure the effective and constructive integration of clinical operations knowledge and expertise into all applicable Clinical Development activities including integrated development plans and study protocols; interact and collaborate with other department heads as appropriate, and internationally based colleagues to align on strategic imperatives.
- Oversee, plan, and implement Quality Checks for clinical projects and provide 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 QA and other groups to develop and follow best practices and SOPs for clinical development.
- Represent all aspects of Clinical Operations and provide updates as required to the Executive Committee, Project Teams, and other key internal stakeholders. Take charge of clinical operations budget.
- Lead & mentor Clinical operations staff to support successful internal training and its implementation and serve as an advocate for professional development of Clinical Operations staff. Mentor clinical operations staff on the Regulatory Inspections process and develop a pro-active approach for Inspection readiness. On behalf of clinical development lead regulatory inspections preparations and take active role in regulatory audits and related actions.
- Maintain accountability for the authorship of operational sections of protocols and investigator brochures and other documents as appropriate and leading the identification of and interaction with investigative sites and investigators, including study execution.
- Develop and maintain strong relationships with CROs, external experts and Investigators to ensure effective execution of internal and external clinical projects. Support, train, guide and supervise clinical operations staff on vendors management and sponsor oversight for clinical trials.
- Coordinate with Data Management/Biostatistics to deliver high quality data deliverables on time and on budget (e.g. development of case report forms, collaboration with statisticians, collaboration with data managers, data overview, clinical study reports, etc.). May have Data Management directly reporting to this role.
- Support CMO in business operations for clinical development activities.
- Provide support for regulatory submissions, supporting dossier development and participating in interactions with FDA, EMA and other regulatory agencies if needed. Support CMO in timelines development, and business operations related to regulatory submissions preparation.
- Keep abreast of competitive regulatory and clinical practices and utilize this knowledge during the ongoing development and adjustment of plans.
Requirements:
- 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; or an equivalent combination of education and experience.
- 5-8 years' experience of In-depth understanding and experience across the clinical operations value chain, with a track record of success in study planning, execution, data cleaning, database locking, study report generation, regulatory filing and regulatory inspection.
- Therapeutic experience in oncology coupled with experience with pivotal, multi-site clinical trials is highly desirable.
- Experience with global drug development and NDA/BLA filing.
- Experience in developing protocols, SOPs, Clinical Study Reports, INDs, NDAs/BLAS as well as other clinical, regulatory, and safety documents; Experience with clinical data management is a plus.
Skills:
- Experience leading a rapidly evolving organization and integrating new personnel is essential, as well as ability to evaluate and resolve complex problems.
- Expertise in clinical operations - demonstrated ability to effectively manage projects and people in fast paced environment.
- Hands on leader.
- Strong communication and presentation skills-demonstrates strong written and verbal communication skills and ability to relay vision/strong sense of department organization, processes, and change to management and staff.
- Must have a 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.
- Self-motivated to maintain expertise in regulatory requirements and guidance to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws.
- Results-oriented team player with strong interpersonal and communications skills, capable of working collaboratively with colleagues located across US and internationally.
- Strategic, visionary thinker, goals driven; Proactive problem-solving abilities and follow-through.
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 to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. 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. Must be able to travel routinely by car and plane.
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. This job requires the person to be mobile to visit company sites. Due to the travel requirements, this position may be exposed to natural elements of nature.
As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights.
Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Join Miltenyi Biotec and immerse yourself in an environment where you can play an integral role in improving patient care from bench to bedside.
Miltenyi Biomedicine, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity
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