Director of senior programs job description

REMOTE WORK APPROVED

The Director/ Senior Director, Clinical Program Quality Assurance is responsible for managing and performing critical Clinical Quality Assurance activities in support of FibroGen Clinical Development programs. This position plays an essential role in ensuring that FibroGen's clinical trials are conducted in compliance with Global Health Authority regulations, ICH Good Clinical Practice (GCP) standards, and internal FibroGen policy, procedures, and processes.

Note: FibroGen Quality reports directly to the CEO. As such, all Quality functions, including Clinical Quality Assurance, are independent Quality units.

Specific Duties
Provide GCP compliance and risk identification/mitigation guidance to clinical Study Operational Teams.Manage the root cause analysis, impact assessment, and development of the relevant CAPAs for significant GCP events in accordance with Health Authority Expectations. Review/assess Clinical Study Protocols/Amendments, Risk Management Plans, Investigator Oversight/Monitoring plans, Informed Consent Form Master Templates, Case Report Forms, and other essential Clinical Study documents prior to final approval and issuance.Partner with Clinical Study Operations Teams in developing study-specific assessments/audit plans (SSAPs), which detail how/when Investigator Sites and Vendors are audited.Perform QA reviews/assessments of in-process clinical trial documentation and associated documents (e.g., Informed Consent Documents, CRFs, Clinical Study Reports, Trial Master File documents, etc.), as appropriate, to ensure compliance with relevant procedures, standards, and regulations.Perform for-cause and directed assessments/audits as needed to support the effective management and execution of Fibrogen's Clinical ProgramsServe as the Clinical Quality Assurance Study Operations Team representative in the Vendor selection and qualification process.Collect and analyze CQA's site and vendor assessment/audit risks with the relevant Study Operations Teams to ensure FibroGen's compliance with ICH E6 (R2)'s expectations for sponsor oversight.Provide training on GCP quality and compliance topics internally (i.e., Clinical Development/Operations, Quality) and externally (i.e., Clinical Investigators, Industry Conferences) Support inspection readiness efforts and revise existing processes (as needed) to incorporate changes to the regulatory landscape and inspection modalities (i.e., remote/hybrid models) Assist/Lead in hosting Sponsor GCP Health Authority inspections and FibroGen partner audits Assist/Lead in the development of Clinical QMS policies and procedures

Requirements:
Minimum of 10 years of GCP Quality/GCP Compliance experience. Additional experience in a Clinical Operations function is preferred. B.S. or M.S. in a life sciences field.Current and strong working knowledge in the interpretation/implementation of Global Health Authority GCP Regulations, ICH/ISO Guidance Documents, and other standards governing Clinical Trials activities.Excellent verbal and written communication skills,Proven ability to lead cross-functional teams, independently prioritize work, and manage multiple projects while maintaining qualityA highly diplomatic, tactful, and detail-oriented approach with exceptional critical reasoning skills Ability to deal with ambiguity, and to develop creative and pragmatic solutions to GCP compliance risk areas Experience supporting regulatory authority inspections is desired.Ideal candidate may work remotely but may be expected to travel up to 20% of the time (post-pandemic) RQAP-GCP certification is a plus.

FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

E-Verify: Notice to all Prospective Employees

Notice to Recruiters and Search Firms
FibroGen makes every effort to source and hire its staff through direct recruitment methods. Employment opportunities at FibroGen are managed by our internal human resources team. Please do not contact hiring managers or other FibroGen employees.

FibroGen does not accept unsolicited resumes from any source other than from the candidates themselves. FibroGen does not accept unsolicited communications from external recruiters. If there is a specific business need, a human resources team member will contact external recruiters directly.

An agency or independent recruiter must have a current, signed agreement and a work order for a specific position with FibroGen before presenting candidates and must be presented to human resources. Submission of unsolicited resumes without a signed agreement and an applicable work order will not create an obligation on the part of FibroGen to pay a fee of any kind.

Date Issued: October 2022

Job Summary:

The Director of Program Success is responsible for working with the executive team to track and oversee multiple programs and projects that will improve program fiscal and program project outcomes. This position will interact with multiple departments and programs, maintain schedules and reports, work with federal and non-federal funders, and complete other projects to increase revenue, reduce cost, and improve profit.-

Proposed position: Sr. Director of Program Success

Purpose: To use business data, analysis, and communication to improve program outcomes.

Major tasks:

1. Work with senior leadership and executives to execute programs, help advance priorities to ensure projects are completed.

2. Maintain a list of data reports (e.g., provider productivity, daily encounters, patient revenue, grant revenue) to ensure validity and to identify trends leading to improved outcomes.

3. Work with CFO and CMO on our comp/bonus model to help build incentive system and then track and monitor periodically.

4. Track and coordinate major grants to ensure deliverables are on time.

5. Work with data analyst position and executives to develop and deliver reports to funders, partners, executives, and board.

6. Work with government programs (e.g., HRSA, county) that fund capital and programs to prevent and troubleshoot barriers to success.

7. Write sections of grant reports and proposals and coordinate collection of data needed.

8. Coordinate with Controller and/or Financial Grants manager to seek more revenue in MCOs and patient revenue.

9. Help prepare monthly agenda, data, and reports for Board of Directors meeting.

10. Coordinate provider productivity reports including merging patient satisfaction, quality, and provider productivity data.

11. Work on new EHR team to help team utilize data analytics reports.

Nonessential Functions:

1. Retrieves voicemails, takes messages from patients, and enters in EMR and routes appropriately.

2. Participates in team/staff meetings; monthly meetings with partner organizations; and attends in service meetings and applicable workshops.

3. Perform other duties assigned by supervisor.

Competencies:

Quality

Respect

Professionalism

Teamwork

Commitment

Supervisory Responsibility

None

Managerial Responsibilities

None

Minimum Qualifications

1. Bachelor’s degree, or equivalent certification of competency, and two (2) years of work experience such as described in the essential work tasks of the job description. Master’s degree in business preferred.

Substitutions

Any combination of education and experience. Incumbent may utilize either of the following options as a substitution to qualify:

1. High school diploma, GED, or equivalent certificate of competency and six (6) years of work experience such as described in the essential work tasks of the job specification.

Competencies Needed

Accountability – Meets established expectations and takes responsibility for achieving results; encourages others to do the same.

Internal/External Stakeholder Management – Ability to focus both internal and external stakeholders simultaneously. Identifying all people or organizations impacted by the program and its projects, and documenting relevant information regarding their interests, involvement, impacts heavily on program and project success.

Knowledge Management – Knowledge base and understanding of the organization and its business practices—as well as familiarity with technologies used in the projects within the program.

Project and Process Management – Ability to manage projects, planning, prioritizing. Appling knowledge, skills, tools, and techniques to project activities to meet project requirements.

Reporting - Drafts, runs, and distributes reports. Provides overview and communicates report findings.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical and Mental Demands

1. Ability to remain in a stationary position 50% of the time.

2. Ability to cope with stress.

3. The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, etc.

4. Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine and computer printer.

5. The person in this position frequently communicates with vendors and/or employees. Must be able to summarize and exchange accurate information.

6. Frequently moves office equipment weighing up to 25 pounds.

7. Performs a variety of duties, often changing from one task to another.

8. Performs with frequent interruption or distractions.

9. Adjust priorities quickly as circumstances dictate.

10. Ability to interact appropriately with colleagues for different purposes in different context.

11. Ability to perceive the nature of sound.

12. Expressing or exchanging information to convey detailed spoken instructions accurately, loudly or quickly.

13. Ability to judge distances and spatial relationships to perceive objects where and as they actually are.

14. Cognitive ability to analyze, count, summarize and synthesize information from multiple sources.

15. Ability to recognize social or professional behavioral cues.

Language Skills

Ability to read and interpret written or verbal documents and instructions. Ability to speak effectively to patients, employees and/or stakeholders of the organization.

Travel

Must be able to drive between Greater Baden Medical Services, Inc. locations.

• Requires Bachelors degree in engineering, computer science, business management or related field with 12 to 15 years experience
• 10 years of program management experience with related experience as the Program Manager for software development contracts
• Demonstrated ability to work and quickly transition across multiple tasks
• Experience managing multiple contract types
• Working knowledge of the customer processes, programs, and policies
• Expert representational, oral, and written communication skills, including the ability to produce clear, logical, and concise products
• Superior organizational and interpersonal skills, and demonstrated ability to interface effectively via written and oral forums with personnel at all levels of government
• Expert skills using MS Office Suite, including Outlook, Word, Excel, and PowerPoint
• Demonstrated expert ability to effectively work with senior and executive level government staff
• PMP or similar Certification
• Active TS/SCI with Polygraph

Peraton Overview

Peraton drives missions of consequence spanning the globe and extending to the farthest reaches of the galaxy. As the world's leading mission capability integrator and transformative enterprise IT provider, we deliver trusted and highly differentiated national security solutions and technologies that keep people safe and secure. Peraton serves as a valued partner to essential government agencies across the intelligence, space, cyber, defense, civilian, health, and state and local markets. Every day, our employees do the can't be done, solving the most daunting challenges facing our customers.

An Equal Opportunity Employer including Disability/Veteran.

For Colorado Residents Colorado Salary Minimum: $128,200
Colorado Salary Maximum: $311,100

The estimate displayed represents the typical salary range for this position, and is just one component of Peraton's total compensation package for employees. Other rewards may include annual bonuses, short- and long-term incentives, and program-specific awards. In addition, Peraton provides a variety of benefits to employees.