VP Clinical Operations - HYRBID
Proclinical is seeking a hybrid VP Clinical Operations for a cutting-edge biotech company located in Lexington, MA.
The Vice President (VP), Clinical Operations is a senior leadership role that contributes to the overall success of the company's novel gene therapy approach through the leadership of all global Clinical Operations to achieve program objectives and ensure the successful completion of clinical trials and key related clinical trial milestones, within established timelines and budgets. The VP will oversee the development of study protocols, clinical trial execution, patient recruitment, clinical compliance/SOPs, safety evaluations, preparation of statistical analysis plans and clinical study reports, data management, medical writing, and outsourcing/vendor management.
Must be eligible to work in the US.
- Works with Chief Medical Officer and/or Head of R&D to establish Clinical Operations organizational structure and required functions and skills required to achieve Clinical Operations objectives and delivery of high-quality outcomes to patients and internal/external stakeholders
- Acts as key resource to the Leadership Team (LT) for business planning regarding expectations, deliverables, and decision making for all clinical program operations, timelines, budgets, and requirements
- Responsible for strategically planning, resourcing, and oversight/execution of clinical trials to achieve program objectives and high-quality deliverables within established timelines and budgets and in compliance with key global regulations
- Drives a culture that values the importance of process/SOP compliance and continuous improvement, including leading department-wide change efforts to implement processes and build/continuously improve Clinical Operations operational excellence in support of planning and conduct of clinical trials to achieve corporate objectives
- Ensures representation of Clinical Operations on all relevant teams, from early discovery through late-stage development and commercialization, to ensure incorporation of Clinical Operations planning into all execution plans
- Oversees outsourcing and vendor management across the department, and ensures efforts to monitor vendor performance are in place and trends/issues are being escalated and addressed appropriately
- Recruits, trains, mentors and retains a top-tier Clinical Operations team to effectively function within the global matrix organization, and to secure the achievement of program and corporate objectives
- Works collaboratively and communicates effectively with all cross-functional and therapeutic area representatives within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals
- Develops and implements resource management and trial metrics tracking tools to measure results to optimize and improve processes and performance
- Utilizes benchmarks and models industry best practices to lead teams to define compliant, efficient, effective and repeatable work processes
- Responsible for implementing a robust Clinical Quality program in collaboration with other functions
- Ensures Clinical Operations is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law
- Oversees Clinical Operations efforts in preparing regulatory submissions, including the planning and implementation of inspection readiness processes in alignment with compliance standards
Skills and Requirements:
- Bachelor's Degree in life sciences; master's degree preferred
- Minimum of 20 years professional pharmaceutical development experience, with a minimum of 8 years of leadership and clinical operations department management experience, and minimum 5 years' experience working in global headquarters environments in either Europe or the US
- Experienced in industry with hands-on expertise and experience covering most or all areas and disciplines of Clinical Operations development and strategic planning; experienced with early to late-stage clinical trials, and with the IND/CTA to BLA/MAA process
- Expert understanding and application of ICH/GPP, EU CTR, and FDA regulations, as well as other GxP regulations in the context of trial execution; deep understanding of regulatory environmental changes and impact on trial design and execution
- Demonstrated ability to effectively lead and direct all disciplines within Clinical Development, including but not limited to Clinical Project Management, Statistics, and Data Management, vendor selection, negotiation, contracting and oversight
- Deep experience in conducting complex clinical research projects and early drug development, with preferred experience in gene therapy
- Demonstrated success in managing Clinical Operations for a product through all clinical phases, product launch and post-marketing commitments
- Demonstrated leadership in Clinical Operations roles, effective organizational skills, and excellent verbal and written communication
- Experience developing, implementing, and leading a broad range of global clinical trials, building global Clinical Operations infrastructure, including SOPs, and managing vendors
- Demonstrated expertise in key global regulations that affect program and trial design, and proactively recommends optimizations to program lifecycle management and country participation considering regulatory environment
- Exceptional ability to build and maintain strong working relationships in departmental and cross-functional efforts of multiple individuals, work groups or teams to accomplish project or corporate goals
- Willingness and ability to travel domestically and international, as required
- Extensive experience with Clinical Operations line management, and mentoring and developing personnel
- Extensive experience negotiating and managing contracts (vendor and site) and clinical finance activities
- Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals
- Independently motivated, detail oriented and good problem-solving ability
If you are having difficulty in applying or if you have any questions, please contact Ciara Noble at +(1) 323-518-2700 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.