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Clinical Operations Asset Lead

Date: Jul 15, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

As a senior member of the Clinical Research and Development Team, the Clinical Operations Asset Lead is responsible for the overall management of one or more programs within the Clinical Operations function, including the implementation, execution and completion of all departmental clinical trials and site selection and management. S/he will also assist (as needed) in development of new programs and departmental initiatives and participate in strategic planning activities throughout the organization. S/he will also be responsible for oversight of studies including but not limited to those for certain programs; this includes designing, planning and implementing overall direction of clinical projects from protocol development, selection and qualification of external service providers/investigative sites through finalization of clinical study reports. S/he will manage the project activities including but not limited to: clinical monitoring, data management, statistical analysis, medical writing, safety monitoring and compliance to insure proper conduct and timely completion of all projects. S/he will be responsible for oversight and management of clinical operations project teams and personnel for the respective programs and will interact with the respective Asset and Brand Strategy teams.

 

Responsibilities:

85%

  • Manage all clinical aspects of the program including: 
    • Plan, execute and manage all aspects of multi-center global clinical trials in compliance with GCPs, SOPs, and within designated program budgets and timelines; 
    • Design and develop (but not limited to) the following program-specific documentation: 
      • clinical development plan; integrated project plan 
      • program timeline and budget
      • risk management plan 
      • educational/training plans 
      • KOL/advocacy engagement plan 
    • Design and develop (but not limited to) the following study-specific strategy tools and processes:
      • investigator/site/country/patient recruitment plans 
      • request for proposal [RFP] processexternal service provider specifications
      • communication plans (including site and sponsor communication as well as site escalation) 
      • ongoing data review plans 
      • risk management plans 
      • study timelines and budgets
      • educational/training plans 
      • performance and compliance metrics 
    • Develop and review (but are not limited to) the following study-specific operational forms and tools: 
      • clinical protocols and amendments 
      • informed consent forms 
      • site feasibility questionnaires 
      • case report forms [CRFs] and CRF guidelines 
      • data / integrated voice recognition system [IVRS] management plans 
      • Investigative site binders, pharmacy brochures, and regulatory binders 
      • serious adverse events [SAEs] forms 
      • statistical analysis plans and data monitoring committee charters 
      • clinical study reports 
    • Collaborate with Legal department and/or clinical research organizations [CROs] to ensure timely review of the confidential disclosure agreements [CDAs] and clinical trial agreements [CTAs]; 
    • Create and manage clinical program/study budgets in conjunction with Project Management and Finance; 
    • Represent clinical study team for study planning and maintenance activities with external service providers, and on internal product development teams 
    • Support selected investigative sites for IRB/IEC submissions, regulatory document collection and review, and budget and contract negotiations in collaboration with Legal and CROs; 
    • Manage and resolve study conduct issues (including protocol deviations, data queries, SAEs/AEs, laboratory discrepancies, and archive reconciliation activities) as applicable; 
    • Plan, execute, and lead study-specific meetings (e.g., Study Management Team [SMT], investigator meetings, advisory committee, etc.); 
    • Provide study-specific training and leadership to internal staff, CRO, sites, external service providers, and other contract personnel; 
    • Prepare and present program debriefings, as required.

 

10%

 

  • Clinical Operations Functional Activities: 
    • Manage/oversee clinical study activities, including clinical budgets and timelines; develop contingency plans for clinical trials 
    • Provide input to Clinical (or other) project teams as needed 
    • Support development of the Clinical R&D function: identify, implement, and manage departmental processes and systems (e.g. eTMF, external service provider selection, SOPs, etc.) 
    • Evaluate and select personnel; manage staffing needs to ensure the efficient operation of the function 
    • Effectively mentor departmental personnel
    • Assist in writing departmental as well as scientific technical documents o Work cross-functionally to develop and implement strategic initiatives

 

5%

 

  • Participate in diligence and business development activities
  • Other duties or projects as assigned
  • Manage Clinical Operations team members to achieve business goals and objectives. 
    • Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish. 
    • Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible. 
    • Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed. 
    • Develop people. Understand each individual team member’s career goals. strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on way

 

 

Requirements:  

 

Education: Bachelor’s degree (minimum); advanced degree in a scientific discipline, or equivalent experience preferred

 

Experience: Required: 

  • A minimum of 12-15 years of related pharmaceutical/CRO clinical trial and site monitoring experience with increasing levels of responsibility. 
  • Candidates must have proven track record for delivering multi-center global clinical projects within time, budget, and quality expectations. 
  • Prior experience managing clinical operations function/personnel.  A balance of scientific and operational/project management and team leadership expertise. 
  • Ability to build effective relationships across, up and down the organization. Preferred: 
  • Experience in operationalizing clinical trials in Rare Disease.

 

 

Competencies: 

 

  • Extensive knowledge of ICH-GCP and FDA regulatory requirements and competency. 
  • Strong clinical study design and management skills, including risk assessment and contingency planning. 
  • Knowledge of clinical trial systems and operational infrastructure (e.g. CTMS, Veeva)  Ability to approach assigned duties in a highly organized, detailed and accurate manner. 
  • Organized and efficient, excellent attention to detail 
  • Excellent leadership skills, oral/written communication, organizational, problem solving, conflict resolution, and team building skills. Ability to manage teams and develop personnel independently 
  • Ability to work cross-functionally with other departments involved in the conduct of a clinical study. 
  • Ability (experience preferred) to work with cross-cultural teams including personnel from global locations as required per project with a positive attitude. 
  • Microsoft Project, Office, PowerPoint and Excel proficiency.

 

 

 

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Nearest Major Market: Philadelphia