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Director Research Regulatory Affairs

Washington, DC, USA | OptiNose, Inc.

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Regulatory Affairs
  • Experience:
    7-10 years
Job Description:
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Reporting to the Children’s National Research Institute’s (CNRI), Vice President of Research Administration, the Director of Regulatory Affairs assumes responsibility – in close collaboration with the Regulatory Affairs Committee Chairs - will oversee the Office for the Protection of Human Subjects (OPHS)/Institutional Review Board (IRB) (85% effort), the Institutional Animal Care and Use Committee (IACUC) (10% effort), and the Institutional Biosafety Committee (IBC) (5% effort). The Director has an integral regulatory leadership role to facilitate research integrity in all stages of research (pre-study stage, active-study stage, post-study stage) and ensure compliance with applicable federal and local laws and regulations, as well as adherence to professional and ethical standards, institutional policies and procedures and observance of good practice quality guidelines (GxP), as they apply to research. These include but are not limited to GCP (Good Clinical Practice), GLP (Good Laboratory Practice), GSP (Good Safety Practice), and GMP (Good Manufacturing Practice). The Director is responsible for the oversight, administration, and coordination of all fiscal, human resources, administrative, and training activities of the regulatory committees (IRB, IACUC, IBC) with the goal to (1) improve the safe and efficient conduct of research, (2) to reduce administrative burden by improving operational efficiency, and (3) to accelerate protocol review and decision turnaround by improving review practices. The Director will develop policies and procedures (P&Ps) and ensure appropriate stakeholders are trained in the P&Ps and following them. This position will include responsibility for protocol review and approval and regular interaction with investigators and their research teams. The Director will manage the functional maintenance of the electronic IRB system that was built on the Click Commerce platform. She/he also will manage the operational aspects of maintaining and improving the functionality of the electronic system for the IACUC and the Research Animal Facility. The Director will serve on institutional research regulatory and compliance committees. The Director will participate in FDA, USDA, and other regulatory site inspections and coordinate internal audits with the research compliance program staff. The Director will manage the AAHRPP and AAALAC accreditation renewals as well as maintain the accreditation status in good standing.


Qualifications


Minimum Education


B.A. (Required).


JD, PhD, MS, MPH or MBA (preferred).


Minimum Work Experience

5 years Management experience with budget responsibility.

8 years Human subjects research leadership experience Progressive relevant experience in a federally funded research organization, overseeing regulatory committee operations, including thorough knowledge of human subject and research animal protection regulations. 


Experience working in an academic medical center IRB office strongly desired.


Advanced level of understanding of operational requirements related to the management and an IRB, IACUC and IBC, in an academic research setting.


Experience with accreditation processes.


Experience with managing electronic regulatory committee review systems.


Required Certification


Certified IRB Professional (CIP) or Certified IRB Manager (CIM)


Certified Professional IACUC Administrator (CPIA)


Required Skills/Knowledge


1. Proven competency and knowledge of the Code of Federal Regulations (CFRs) with respect to human subjects and research animals.

2. Knowledge of best practices in Federal Wide Assurance and Human Subjects Research.

3. Advanced technical competence in wide range of research compliance issues.

4. Advanced legal knowledge in risk management as applied to clinical research.

5. Superior ability to manage relationships with researchers, staff and regulatory agencies.

6. Experienced and proficient in balancing regulatory compliance requirements against practical needs and limitations.

7. Highly experienced program development and problem solving techniques.

8. Ability to network and interact, as well as support effective partnerships with key groups and individuals.

9. Ability to prioritize ongoing and new projects, as well as conduct internal research and gather information.

10. Ability to consult with clients and apply change management skills to influence formal and informal networks within the organization.

11. Ability to network and build effective, responsive relationships between researchers, academic/administrative departments and regulatory staff.


12. Ability to lead change.

13. Demonstrated leadership and management skills. Excellent interpersonal as well as written and verbal communication skills.


14. Experience in budget development and managing fiscal and operational aspects of a large department.


Functional Accountabilities


Responsible and Compliant Conduct of Research


1. Ensure compliance with standards for the responsible conduct of research..

2. Plan, conduct, and manage research projects within the federal and institutional regulations and policies under the direction of the principal investigator.

3. Develop compliance strategies to meet applicable CFRs and institutional policies while minimizing administrative burden on investigators and regulatory staff.

4. Monitor and analyze current and proposed federal and state policies and regulations and recommend changes in institutional policies and procedures to ensure compliance.

5. Maintain Responsible Conduct of Research (RCR) principles and training; will determine, communicate, and establish an institutional training program; coordinate or conduct workshops and seminars on protecting human subjects, using research animals, using recombinant DNA, viral vectors and select agents in research.


Execution of Vision and Strategy into Optimal Organizational Performance


1. Plan, implement, direct and evaluate assigned department on a strategic and operational level to ensure the organization's move to Top Tier and Employer of Choice.

2. Monitor department processes and seek opportunities to improve operations.

3. Develop programs to enhance the operations of the department and to increase the ability of researchers to conduct research in compliant and ethical manner.


Program and Service Administration and Implementation


1. Help develop strategic plan; execute strategic plan through management of day-to-day operations of the department.

2. Ensure compliance with organizational and departmental policies and procedures, and CFRs; ensure adherence to GCP guidelines.

3. Develops and administers the policies and procedures for human subjects in research, animals in research, recombinant DNA, viral vectors and select agents in research, and the responsible conduct of research. Ensures that the staff, committee members, and investigators are well trained and practice research and review of research in accordance with CFRs and institutional policies and procedures.

4. Identify the potential in and understand the use of administrative and clinical information resources and decision-support tools in process and performance improvement.

5. Demonstrate proficiency in compiling and analyzing data to present to the executive leadership.

6. Focuses on results to be achieved, promote best practices, measure performance, maintain HRPP performance metrics and make adjustments to improve both efficiency and effectiveness.


Budget and Finance Management


1. Independently develop and monitor operating budget.

2. Monitor performance reports and evaluate budget variances.

3. Consistently utilize cost effective resources.

4. Consistently meet budget and staffing requirements.

5. Incorporate budget considerations in all planning and decision making.


Organizational Relationships


1. Assess and monitor organizational staffing requirements and align resources to effectively and efficiently meet organizational needs.

2. Define, set, and utilize appropriate performance and quality measures for the department and for individual staff members.

3. See oneself as a leader of others, from forming a top team that possess balanced capabilities to setting the mission, values and norms, as well as to hold the team members accountable individually and as a group for results.

4. Establish, build, and sustain professional contacts for the purpose of building networks of people with similar goals that support similar interests.

5. Demonstrate ethics and professional practices, as well as stimulate social accountability and community stewardship.


Leader Accountabilities Director


Deliver


1. Set and achieve departmental goals.

2. Align budgets and resources to meet division goals.

3. Monitor and support a safe and quality environment.

4. Focus the team on service excellence and make the interdepartmental connections needed to ensure high service.


Engage


1. Clearly communicate organizational strategies to the department.

2. Ensure managers hold the team accountable for high performance.

3. Support managers in maintaining a positive working environment.

4. Represent the department in clearing obstacles to high performance.

5. Look for and develop high-performing talent.

6. Support supervisors and managers in engagement efforts.


Grow


1. Look across departments for opportunities to make the organization more effective.

2. Recognize and share innovation and improvement.

3. Represent the department in organization-wide innovation and improvement efforts.


4. Monitor and grow the department’s capacity for change.


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