Director of Data Management and Services

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MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics prioritizing public benefit above profit. Founded in 2014, MAPS PBC is a wholly owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) a 501(c)(3) nonprofit. More information about the organization is available at mapspublicbenefit.com.

MAPS PBC is committed to the evolution of psychedelic healing modalities. We are building a diverse and inclusive workplace where we learn from each other. We value transparency, autonomy, experimentation, and kind, direct feedback. We welcome applicants who thrive in the midst of a growing organization that values science and healing.

MAPS PBC advances equity and inclusion in the workplace by providing equal employment opportunity to support a work environment free from discrimination on the basis of race, religious creed, color, national origin, ancestry, physical disability, mental disability, medical condition, genetic information, marital status, sex, gender, gender identity, gender expression, age, sexual orientation, military and veteran status, arrest or conviction record, and any other basis prohibited by law. The organization also provides reasonable accommodations for qualified applicants and employees with disabilities. This equal employment opportunity policy applies to all aspects of employment, including recruitment, selection, advancement, training, problem resolution, and separation from employment. Through this policy, MAPS PBC strives to establish and maintain an equitable and accessible work environment that is supportive and free from discrimination.

Call for Candidates

MAPS PBC is seeking an accomplished professional who thrives in a fast-paced environment and expertly drives clinical data management, automation, technology, and data science initiatives to deliver results in accordance with the company mission and objectives. Reporting to the Deputy Director and Head of Research Development and Regulatory Affairs, the Director leads the Data Services Department which includes Data Management, Data Science, and Clinical Systems Teams. The Director provides strategic influence to develop technical documents for investigational new drugs and datasets for submission to regulatory agencies around the world. The Director promptly resolves challenges while facilitating process improvements and synchronizing objectives in complex environments. Suitable candidates are able to work well in a fast environment and adept at organizing and managing lots of information virtually, using required project management systems in a consistent manner.

Interested and qualified candidates are encouraged to apply online here.

 

Location

This is a remote position from a suitable home office with a private and quiet area to work. Secure internet and reliable phone reception are required. This position requires frequent phone and internet video meetings. Certain home office expenses may be reimbursed. A work computer will be provided. The MAPS PBC headquarters office is located in Santa Cruz, CA. Occasional travel may be required. Bay Area candidates preferred.

 

Hours

Full-time, exempt, salaried position. Must be available during normal business hours for a California-based company. Some night and weekend hours may be required.

 

Position Duties

  • Develop and lead virtual teams that include Clinical Data Managers, Clinical Data Scientists, Statistical Programmers, Statisticians, Application Managers, and Superusers
  • Manage the quality, accuracy, and traceability of final statistical packages in accordance with Statistical Analysis Plans, Clinical Data Interchange Standards Consortium (CDISC), Tabulation Datasets (SDTM), Analysis Datasets (ADaM), and Nonclinical Datasets (SEND) for development of NDA and marketing authorization application submissions
  • Lead production of Investigator Brochures (IB), Clinical Study Reports (CSRs), and Development Safety Update Reports (DSUR)
  • Oversee vendor selection, management, and oversight for biostatistics, analysis programming, databases, and clinical systems
  • Drive development and implementation of cloud-based Software-as-a-Service systems to serve multiple business needs and validate to Title 21 CFR Part 11 as needed
  • Oversee clinical system and software development through the lifecycle including evaluation, implementation/development, maintenance, archiving, and documentation
  • Provide strategic and tactical input on the planning and execution of cross-functional projects
  • Responsible for technical input into the creation of clinical study protocols, databases, statistical analysis plans, tables, figures and listings
  • Serve as liaison between Data Services teams and the business areas: Quality Assurance, Regulatory Affairs, Clinical Operations, Project Management

People Management:

  • Oversee planning, monitoring and management of Data Services staff
  • Lead by example by living and enforcing company values
  • Lead and contribute to departmental and cross-functional process improvement initiatives
  • Builds teamwork and improves process and productivity by working within and across functional areas
  • Facilitates team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans
  • Ensure that Data Services staff work efficiently on cross-functional projects
  • Responsible for the training of staff to ensure optimal performance and compliance with MAPS PBC systems and processes
    • Ensures staff fulfill MAPS PBC policies, procedures, and SOPs
    • Provides core systems training and enforce compliance with systems, processes and policies and all applicable regulations
    • Participates in development and deployment of functional area training
    • Analyze key performance indicators, identifying root causes of poor performance and implementing corrective actions
  • Responsible for career development, assessment, feedback, and retention of Data Services staff
    • Identify competencies and skills required, select and recruit staff, define appraisal, skills, and pathways for potential career path development
    • Collaborates with project teams in assessment of staff performance
    • Ensure oversight and maximize performance of project team’s planning, execution and risk management
    • Train staff to ensure optimal performance and compliance with MAPS PBC systems and processes
      • Ensures staff fulfill MAPS PBC policies, procedures, and SOPs
      • Provides core systems training and enforce compliance with systems, processes, policies, and all applicable regulations
      • Participates in development and deployment of functional area training
      • Analyze key performance indicators, identifying root causes of poor performance and implementing corrective actions
    • Oversee the career development, assessment, feedback, and retention of Data Services staff
      • Identify competencies and skills required, select and recruit staff, and define appraisal, skills, and pathways for potential career path development
      • Collaborate with project teams in assessment of staff performance

    Ensure oversight and maximize performance of project team’s planning, execution, and risk management

    Minimum Requirements:

    • M.S. in scientific discipline, advanced degree preferred
    • 8+ years of experience in clinical development within the pharmaceutical industry with significant exposure to global teams
    • 5+ years of experience in program management and leadership of cross-functional teams with demonstrated ability to drive projects to completion
    • Experience and training in ICH Guidelines and other applicable regulatory requirements
    • Experience filing New Drug Applications strongly preferred
    • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook) and project management applications

    Additional Competencies:

    • Posess a confident and influential approach
    • Able to contribute to highly technical and detailed documents
    • Able to lead, motivate, and understand highly technical teams
    • Communicate and collaborate with key players as well as internal and external staff with strong interpersonal skills
    • Posess good problem analysis and problem solving skills
    • Proactively work to streamline workflows, build efficiency, security and user interface of various platforms
    • Posess excellent written and verbal communication skills
    • Make informed decisions, where appropriate, based on input and guidance from others and take responsibility for actions
    • Maintain strong organizational skills with attention to details and timelines
      • Able to work quickly in a remote virtual setting
      • Able to use the following tools with some training (previous experience a plus): Microsoft Office 365 Applications (Word, Excel, PowerPoint, Outlook, SharePoint), Smartsheet, Zoom and Asana

       

      Compensation

      This position is exempt from overtime. Salaried compensation commensurate with experience, range available upon request. Full benefits package included.

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MAPS PBC is a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS). MAPS is a 501(c)(3) non-profit research and educational organization.