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#106821 Program Manager

Company: University of California - San Diego Medical Cente
Location: San Diego
Posted on: November 23, 2020

Job Description:

#106821 PROGRAM MANAGER

Filing Deadline: Wed 11/25/2020

This is a UC San Diego internal recruitment open to UCSD and UCSD Health System staff only.

UCSD Layoff from Career Appointment: Apply by 11/20/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 11/25/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

In an environment of great scientific and operational complexity and very little precedent, under the guidance of the Principal Investigator, the Program Manager (PM) will be an imperative role for an $12 million dollar, 4-year long, CLIN2 clinical stage program, after successfully completing an $5.2 million dollar, multi-year, time-critical, CLIN1 program both funded by the California Institute for Regenerative Medicine (CIRM).

The ongoing CLIN2 program is for a first-in-human, Phase 1/2 clinical trial for a rare genetic disorder. After successful submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) and achieving all the Operational Milestones of CLIN1 program, the incumbent Program Manager will continue to serve as an Operational Manager and a Regulatory and Clinical Affairs lead, to a cross-functional research team, clinical trial staff, nursing and pharmacists staff in order to adhere to multiple overlapping compliance guidelines by Federal regulations, those stated by the state funding agency; UCSD IRB regulations; Investigational Biosafety Committee (IBC) policies; and Good Clinical Practices (GCP) for the purpose of establishing clinical research and development activities necessary. The incumbent will be accountable for managing and oversight of Contract Manufacturing Organization (CMO) and Contract Research Organization (CRO) activities in order to make sure project timelines, budget and milestones are met.

The incumbent oversees development of clinical protocol by managing all aspects of Phase I/II clinical trial including trial implementation and execution, quality and compliance, strategic planning and program management. Responsible for overall conduct of the program at various stages of clinical development, implementation and closeout by managing communication with investigator physicians and supporting staff working at various UCSD and Rady Children s Hospital locations, serve as a program manager and primary liaison by building collaborative clinical trial team focused on the efficient management of clinical trial. Additional responsibilities include management and prioritization of queries from California Institute of Regenerative Medicine (CIRM), Contract Research Organization (CRO), Contract Manufacturing Organization (CMO), individual investigators, nursing staff, clinic staff, pharmacists from several entities within UCSD.

Participate in research grant opportunities and drafting grant proposals as required by contributing in developing Gantt charts, timelines, operational milestones, outlining various processes involved in Chemistry, Manufacturing and Controls (CMC) aspects of the clinical trial investigational cell and gene therapy product.

As a regulatory expert, the Program Manager will also provide recommendations based on knowledge of rules, regulations and guidance governing drugs, biologics in all phases of cell and gene therapy product development. In conjunction with the Principal Investigator the Program Manager will oversee conduct of the program and leverage management knowledge and prior experience of conducting clinical research in the drug development industry to organize important aspects of program activities such as ensuring FDA, GCP, compliance, navigating through regulations, creating best practices, developing goals, establishing timelines, tracking and coordinating efforts across team members, facilitating effective information flow, responsible for both scientific timelines and financial accountability.

The Program Manager will serve as a liaison between UCSD, Sanford Consortium for Regenerative Medicine, vendors, subcontractors, US and state government agencies, and will participate in ongoing communication and documentation with CIRM. The Program Manager will use good judgment to create and incorporate strategies to ensure that key decision points and program goals are met.

Program activities include but are not limited to quarterly and operational milestone reporting to the funding state agency, quality assurance and data verification activities for operating procedures and document control, regulatory and clinical strategy tasks to meet FDA guidelines for IND filings which include Annual Reports, . The PM will proactively drive planning and execution of the program strategy; this will involve oversight of program plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables. The PM is responsible for promoting a collaborative team environment and maintaining positive team dynamics to enable on time execution. A strong emphasis on effective meeting management, transparent team communication, efficient decision-making, proactive risk management, conflict resolution and problem-solving is required.

MINIMUM QUALIFICATIONS

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Bachelor's Degree in related area; and/or equivalent experience/training.
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A minimum of five (5+) or more years of relevant research experience.
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Advanced knowledge of clinical research practices and philosophy, and ability to apply knowledge and skills to recommend improvements in methodology. Advanced knowledge of regulatory requirements.
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In depth critical thinking skills to evaluate issues and identify a potential solution. Creatively addresses complex or new problems. Exercise good judgement in elevating and communicating actual or potential issues to line management and presents solutions to those issues.
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Advanced communication, verbal and written skills, active listening, critical thinking, persuasiveness, advising and counseling skills. Clear and concise communicator. Ability to interface appropriately (with diplomacy and confidentiality) with campus staff and investigators.
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Advanced interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership with other team members. Works well with others to achieve common goals.
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Proven ability to perform all commonly applicable functions in word processing and spreadsheet software. Advanced knowledge of clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
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Theoretical knowledge of Stem Cell biology.
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Demonstrated experience with clinical protocol development and design.
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Proven experience in IND submissions, electronic Common Technical Document (eCTD), Orphan Drug Designation application, regulations for drug products for pediatrics population, FDA interactions and regulatory document development in support of clinical trials, particularly in the field of stem cell based gene therapy.
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Solid knowledge and understanding of relevant FDA regulatory guidance documents (for Cell and Gene Therapeutics, Device, Diagnostic projects).
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Experience developing clinical trial documents including Informed Consent Forms, Clinical Trial Protocols, Research Plans, Source Documents, paper based and electronic Case Report Forms (CRF), FDA Form1571, 1572, 3454, 3455, Adverse Event forms, etc. per local and central IRB requirements. Working knowledge of GLPs, GMPs and GCPs.
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Demonstrated experience managing complex pre-clinical and clinical programs with tight operational milestone
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Experience in Program Management best practices: communication, scheduling, budget & resource planning, team building and risk management.

Keywords: University of California - San Diego Medical Cente, San Diego , #106821 Program Manager, Executive , San Diego, California

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