Director Clinical Trial Disclosure Operations
Director Clinical Trial Disclosure Operations
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$ 169700 - 282900
1 Vacancy
Job Description
Role Summary
The Director Clinical Trial Disclosure Operations is responsible for overseeing the endtoend management of clinical trial disclosure operations and activities. This role ensures compliance with global regulatory requirements and corporate mandates and involves oversight of colleagues and/or contractors on the Clinical Disclosure Team and partnership with internal stakeholders involved in the processes. The Director will ensure the operational and compliance with internal polices aligned to Pfizers public disclosure of clinical trial information and commitments with a focus on continuous improvement of processes. The Director will work collaboratively with key internal and external stakeholders to develop solutions that support current and evolving regulatory compliance needs.
Role Responsibilities
Operational Oversight:
Proficient in project and people management with comprehensive knowledge of clinical trials including protocol development data management data analysis and study reporting.
In collaboration with internal stakeholders and with the Sr. Director Clinical Disclosure and Expanded Access Lead translate regulatory requirements US EU and country specific) as well as Industry/PhRMA guidelines into standards and processes that allow Pfizer efficiency and effectiveness in meeting compliance. Be aware of new and changing requirements and technologies and develop solutions to support such regulatory compliance needs.
Function as a point of contact for clinical trial disclosure queries internal audits external inspections and acquisitions/divestitures. Resolve escalated process issues and questions. Serve as a subject matter expert and represent the organization on various teams and taskforces as needed.
Team Management:
Oversee a team of colleagues and contractors performing daytoday operational activities in support of Clinical Trial Disclosure. Develop resourcing models to support Pfizers portfolio of clinical trials ensuring processes are efficient for those involved.
This includes on/off boarding training and resource management. Perform operational activities as needed.
Compliance and Audit Readiness:
Ensure processes are inspection and audit ready manage remediation activities and continuously improve processes.
Stakeholder Collaboration:
Work with internal stakeholders including but not limited to Clinical Medical Statistics Medical Writing Legal Compliance Intellectual Patent Attorneys Regulatory Medical Quality and Enablement Teams and ad hoc project teams to ensure understanding and compliance with regulatory requirements and Pfizer strategy for disclosure activities
Policy and Governance:
As worldwide regulations and corporate mandates evolve work with Team Lead and stakeholders to be aware of new and changing requirements and technologies and develop solutions to support such regulatory compliance needs. Participate in and lead governance and policy groups providing expertise on public disclosure of clinical trials. Influence stakeholders to shape Pfizers policy and operational aspects to fulfill compliance needs.
Process Improvement:
End to end operations management of clinical trial disclosure in compliance with Pfizer GSOPCT28. Collaborate with disclosure system administrators and digital teams for continuous improvement of the clinical trial disclosure management system.
Metrics and Reporting:
Implement and report relevant public disclosure metrics. Establish and track key performance indicators (KPIs) to measure and optimize disclosure operations.Keep records accessible for inspection and resolve compliance issues found through metrics.
Minimum Requirements
Advanced degree (MS MPH RN) in life sciences drug development or a related field
Minimum 10 years of experience in clinical study management clinical monitoring or clinical trial disclosure
Indepth understanding of global regulatory requirements related to drug development and public disclosure
Proven history of meeting regulatory compliance needs and managing multiple clinical studies
Experience in optimizing operations for complex processes and developing/implementing new processes within an organization
Ability to manage direct reports and coach team members across multiple sites.
Excellent project management skills and success working in a highly matrixed environment
Excellent verbal and written communication skills
Preferred Requirements:
Experience in audit/inspection and risk mitigation
Demonstrated ability to interpret study data translating findings to identify potential risks
Experience in resolving escalated process issues and questions
Strong analytical skills and ability to review metrics across the organization/enterprise/portfolio for trends
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex data analysis and understand regulatory documents/regulations
NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Some travel for team and department meetings and training
Ability to accommodate global/virtual meetings outside of normal working hours
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care providers name address and the type of payments or other value received generally for public disclosure. Subject to further legal review and statutory or regulatory clarification which Pfizer intends to pursue reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse your name address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an EVerify employer. This position requires permanent work authorization in the United States.
Required Experience:
Director
Employment Type
Full-Time
