VP, Clinical Operations - Lexington

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Active since 30-10-2018 Job category Science, research & development
Location Lexington Level Manager
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization

uniQure is dedicated to bringing therapies for unmet medical needs to patients. In doing so each function in uniQure is directly or indirectly responsible for the life of patients. This responsibility should be part of our day-to-day working life (i) by living up to high quality standards and (ii) by recognizing the sense of urgency in areas of high medical need.

The VP, Clinical Operations contributes to the overall success of our novel gene therapy approach. The VP, Clinical Operations is a senior leadership role taking on the leadership of all global Clinical Operations of uniQure to achieve program objectives and ensure the successful completion of all clinical trials and related clinical trial milestones within established timelines and budgets. The VP will oversee the development of study protocols, clinical study execution, drug supply, EC/IRB submissions, DMC charters, patient recruitment, clinical study monitoring, clinical compliance/SOPs, safety evaluations, preparation of statistical analysis plans and clinical study reports, data management, medical writing, and vendor management. In addition, the VP will serve as a role model for senior leadership within the company and with external stakeholders.

Key result areas (major duties, accountabilities and responsibilities):

  • Responsible to work with CMO to establish clinical operations organizational structure and required functions and skills to achieve clinical operations objectives
  • Key resource to the LT for all business planning regarding expectations, deliverables, and decision making for all clinical program operations, time-lines, budgets and requirements. Establish realistic budgets and time-lines for approval on all projects
  • Responsible for strategically planning clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high-quality deliverables within established timelines and budgets.
  • Implement processes and build a Clinical Operations organization that excels effectively within a matrix organization to successfully support the planning and conduct multiple clinical trials in early to late stage to achieve corporate objectives.
  • Insure representation of clinical operations on all PM teams from early discovery through late stage development through commercialization to incorporate clinical operations planning into all PM plans
  • Ultimately responsible for vendor management, RFP process and delivery of vendor deliverables
  • Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, vendor management and oversight, policies, systems, and processes across all trials.
  • Responsible for recruiting, training, mentoring and retaining top-tier clinical operations teams to effectively function within our global matrix organization and to secure the achievement of program objectives.
  • Provide a senior role model for leadership to the clinical operations team, and across the matrix organization, by effectively communicating a vision for the success of our programs, establishing a clear strategy for achieving the objectives of an expanding matrix organization and pipeline, fostering team work to ensure timely and high-quality deliverables, demonstrating efficient and clear decision making, fostering principles and values that place patients and quality first, supports the mindset of a matrix organization and maintaining an “executive presence” to inspire and guide people in attainment of individual and corporate goals.
  • Effectively identify, manage and maintain skilled oversight of external vendors to provide high-quality deliverables within established timelines and budgets.
  • Work collaboratively and communicate effectively with all 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.
  • Develop and implement resource management and trial metric tracking tools and establish performance goals by role. Develop and maintain systems for effectively managing service provider relationships. Responsible for instituting a clinical Quality program in collaboration with other functions.
  • Ensure 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.
  • Ensure clinical operations is prepared for regulatory submissions and inspection ready as well as meets all compliance standards

Qualifications & Skills:

  • Master’s degree in Life Sciences
  • Minimum of 15 years professional pharmaceutical development experience, with a minimum of 8 years leadership experience and an estimated experience of 5 years from working in a global headquarter environment either in 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.
  • Demonstrated ability to lead and direct all disciplines within clinical development including clinical project management, statistics, data management, vendor selection, negotiation and contracting and vendor oversight.
  • Demonstrated capability to manage clinical operations for a product through all clinical phases, product launch and post-marketing commitments.
  • Demonstrated leadership in a clinical development roles, effective organizational skills, and excellent verbal and written communication.
  • Willingness and ability to travel domestically and international as required.
  • Experience developing, implementing and leading a broad range of clinical trials both in the U.S. and ex-U.S., building global clinical operations infrastructure out of headquarter perspective, including SOPs, and managing vendors.
  • Experience with Clinical Operations line management, and mentoring and developing personnel.
  • Extensive experience negotiating and managing contracts (vendor and site) and clinical finance activities.
  • Excellent working knowledge of FDA & ICH/GCP regulations and guidelines.
  • 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.

Core competencies:

  • Ability to work in a team environment, meet deadlines, and prioritize and balance work from multiple individuals.
  • Ability to lead and direct towards ambitious goals and deliverables with demonstrated focus on value generation as the primary objective for clinical development.
  • Independently motivated, detail oriented and good problem-solving ability.
More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Biotechnology
Region United States

Contact information

Name Jennifer Wagner