Director of Data Management and Services - REMOTE POSITION

Data Services · Santa Cruz, California
Department Data Services
Employment Type Full-Time
Minimum Experience Senior Manager/Supervisor

About MAPS Public Benefit Corporation (MAPS PBC):


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) non-profit organization.  More information about the organization is available at http://www.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.


We believe in diversity and inclusion of people of all backgrounds, genders, races, ethnicities, sexual orientations, educational backgrounds, military and veteran status, religions, abilities, and perspectives. MAPS PBC values and seeks applicants who are people of color, queer, transgender, gender non-conforming, and gender fluid. MAPS PBC strives to establish a supportive, equitable and accessible work environment.


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.


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
  • Responsible for 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, 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 processeso   Ensures staff fulfill MAPS PBC policies, procedures, and SOPs


          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 action

  • 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


Minimum requirements:


  • MS 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:


  • Confident and influential approach
  • Ability to contribute to highly technical and detailed documents
  • Able to lead, motivate and understand highly technical teams
  • Communicate and collaborate with key players, internal and external staff with strong interpersonal skills
  • Good problem analysis and solving skills
  • Proactively work to streamline workflows, build efficiency, security and user interface of various platforms
  • Excellent written and verbal communication skills
  • Make informed decisions based, where appropriate, on input and guidance from others and take responsibility for actions
  • Strong organizational skills with attention to details and timelines
  • Able to work quickly in a remote virtual setting
  • Ability 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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  • Location
    Santa Cruz, California
  • Department
    Data Services
  • Employment Type
    Full-Time
  • Minimum Experience
    Senior Manager/Supervisor