Senior Director FSP Operations

The Senior Director, FSP Operations will be responsible for driving and overseeing the scope and execution of operational activities within FSP programs. This position is responsible for creating or enhancing the FSP infrastructure and processes within the applicable region/country according to laws and regulations. This role provides oversight of the FSP Program Managers in managing the scope of work, objectives, program plans, quality of deliverables, and other activities of FSP projects, which may be global and multi-functional in scope. Additionally, this position will oversee Talent Delivery processes and execution for FSP programs.

The Senior Director, FSP Operations will work to support the team in areas including but not limited to staff development/training, financial forecasting, budget planning and P&L management, policies, procedures and processes as well as support of business development and marketing activities. The Senior Director, FSP Operations collaborates with Business Development to support and offer strategy, review and edit proposals, finalize program budgets and scope of work and oversees management of program budget(s) to meet departmental and corporate financial goals and customer satisfaction.

Responsibilities:

• Managerial Responsibilities:
  1. Support of P&L management for FSP programs within Advanced Clinical Solutions Business Unit
  2. Oversight of the delivery services for FSP programs, ultimately ensuring customer satisfaction.
  3. Responsible for day-to-day performance management and skills development of assigned direct reports.
  4. Execute strategy for continuing cross-departmental collaboration and company growth, and provide hands-on leadership to create a results-oriented, client focused, team environment.
  5. Implement technology solutions to create efficiencies and enhance the service offering for FSP programs.
  6. Maximize productivity to exceed budget goals.
  7. Development of new processes and identification of improvements to current processes, and initiate a plan to improve or develop said processes.
  8. Responsible for recruitment, hiring, onboarding, training, management and offboarding of FSP Program Managers and FSP team members
  9. Coordinate Program Manager assignments across programs to ensure all targets and deadlines are met.
  10. Direct the process and requirements for FSP candidate recruitment and hiring with the Talent Delivery team.
  11. Conduct evaluations for direct reports according to company policy and procedures.
  12. Standard Operating Procedures (SOPs)
      1. Be familiar with and follow department SOPs.
      2. Ensure staff is adequately trained on and following SOPs
      3. Create and review SOPs to recognize and prevent potential regulatory and/or performance issues.
      4. As required by FSP program, work with team and client to ensure staff has proper access to client SOPs and systems and complete appropriate training requirements.

• Business Development
  1. Assist with RFP/RFI completion.
  2. Provide strategy and pricing approval for proposals, including working with Recruitment, Proposals, and Talent Delivery team on pay and bill benchmarks.
  3. Attend sales meetings as requested by Business Development, including capabilities and bid defense meetings
  4. Participate in governance board meetings with clients as appropriate
• Other Responsibilities
  1. As needed to support the team, participate in or take responsibility for Program Management: updating, compiling, and reporting various clinical tracking information; managing clinical studies; and any other tasks within the scope of program management.
  2. Work with other Functional and Departmental Leaders across Solutions and Strategic Resourcing as needed, to support a unified offering.
  3. Participate in clinical training programs and developmental programs in the field of clinical research, as needed.
  4. May participate in program management quality or process initiatives.
  5. Assist as requested within strategic company initiatives.
  6. Travel required for business development support, client meetings, partner meetings, vendor meetings. Approximately 10%-15%
  7. Perform other duties as requested by management.
  8. Participate with Marketing toward corporate objectives.

Qualifications:

• Education: Bachelor's degree in a healthcare or scientific discipline with 12 years of pharmaceutical and/or device industry experience working on clinical trials and 7 years of experience in a team leadership capacity or equivalent combination of education, training and experience. FSP experience is preferred.
• Training: GCP (including 21 CFR 11 and E6R2), HIPAA - Privacy Rule and Protected Health Information, GDPR
• Certification: None required, PM Certification or Healthcare licensures or certifications would be considered a plus.
• Experience:
  1. Exceptional team leadership skills and proven industry vision.
  2. Efficient and effective time management skills with ability to successfully manage competing priorities.
  3. The ability to establish and maintain effective working relationships with executive management, coworkers, managers and clients.
  4. Effective and professional presentation skills, including a credible presence in front of potential customers.
  5. Excellent organizational and problem-solving skills.
  6. Advanced knowledge of, and ability to apply GCP/ICH and all applicable regulations and guidelines.
  7. Superior written and verbal communication skills including excellent command of English with computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint.

Advanced Clinical is a clinical development and strategic resourcing organization committed to providing a better clinical experience across the drug development journey. Our goal is to improve the lives of all those touched by clinical research - approaching each opportunity with foresight, character, resilience and innovation. Based on decades of experience, we help our clients achieve better outcomes by conducting candid conversations and anticipating potential issues through our customized solutions.