- College of Medicine at the Milton S. Hershey Medical Center
- Date Announced:
- Date Closing:
- open until filled
- Job Number:
- Work Unit:
- Penn State College of Medicine
- Public Health Sciences
The Schmitz Laboratory at the Penn State Hershey Medical Center seeks to become of the nation’s premier educational and research exercise science laboratories developing behavioral interventions within a diverse array of patient populations and across multiple disease entities, principally cancer. Our faculty and staff will be the most important asset in our pursuit of achieving excellence in education, research and community service. Our staff will not only enjoy outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement, artistic pursuits, and natural beauty. OVERVIEW: The Schmitz Laboratory (Schmitz Lab) at the Penn State College of Medicine was established within the Department of Public Health Sciences in 2016. The overarching goals of the Schmitz Lab are to: 1) Conduct clinical research on energetics and cancer and other diseases of public health significance, 2) Translate effective energetics interventions into clinical cancer care in a manner that will be broadly disseminable, 3) Conduct observational analyses and translational research on pathogenesis and new intervention targets, and 4) Mentor graduate students as well as domestic and international collaborators in clinical and translational research. The four areas of research that form the focus of the laboratory include: 1) Trandisciplinary research on energetics and cancer. 2)Cancer rehabilitation and cancer survivorship research. 3)Mobile health solutions to improving exercise and weight control in clinical populations. 4)Precision Exercise Medicine. POSITION SUMMARY: The Schmitz Laboratory has an outstanding opportunity for a full-time Senior Instructor, acting as a Director of Operations for the Schmitz lab. This position is part of the leadership engaged in strategic planning and managing organizational development during a time of initiation and subsequent growth of the Laboratory at the Penn State Hershey College of Medicine. Dr. Schmitz and her team is renowned for its contributions to the field of physical activity interventions within a diverse array of patient populations and across multiple disease entities of public health importance including cancer, cardiovascular disease, and others. The Schmitz Laboratory is positioned to ask important research questions from multiple orientations, including epidemiology, basic sciences, and behavioral and biomedical interventions. Transdisciplinary research is a hallmark of the Schmitz lab. The Director of Operations will be pivotal in developing the team and processes to support an expanding portfolio of externally funded research programs in the areas of energetics and cancer, cancer rehabilitation, survivorship cancer care delivery, mobile health solutions to delivering exercise and weight loss interventions to clinical populations. The Director of Operations has a comprehensive range of responsibilities for laboratory operations spanning multiple projects and funding sources. This position is directly responsible for all central functions and staff acquisition and management. It is anticipated that when the lab is fully functioning, there will be 10-15 highly competent staff specializing in study operations, regulatory affairs, data management and analysis, specimen repository, and other clinical operations. Additional core competencies for this position include technical and professional knowledge relevant to clinical and translational research, the scope of research conducted by the lab, professionalism, strategic leadership, strong communication and organizational skills. Critical knowledge and skills for this position are organized into the following areas: Programmatic and Strategic Planning, Financial Management, Personnel/Human Resources Management, Regulatory Affairs, Research Protocol Development and Data Management, Specimen Repository Operations, Quality Assurance, and Research Operations. S/he often acts in an advisory capacity to the Chief Scientific Officer and Principal Director (Dr. Schmitz), investigators, and staff; and frequently serves as the primary operational interface of the Schmitz Lab with multiple University departments and non-university partners who collaborate with the laboratory in research and training related activities. Given Dr. Schmitz role as the Associate Director of the Population Sciences program at the Penn State Cancer Institute, the Director of Operations will also be intimately involved in operational direction of the Population Sciences program at the Penn State Cancer Institute. The Director of Operations: Serves as the staff executive head, reporting to Dr. Schmitz (the Chief Scientific Officer and Principal Investigator). Provides top-level managerial leadership for the lab. Along with Dr. Schmitz and other Faculty as appointed by the PI, sets the vision for programmatic, financial, and facility needs, including for the population sciences program, not just the Schmitz lab. In addition, ensures that all activities within the Schmitz Lab comply with state and federal policies as well as the policies and laws of the host countries for international research. Has a high degree of independence in research-related administration of the Schmitz lab, soliciting direction from the lab Faculty and Leadership, and collaborating with a wide range of program staff in developing and implementing processes. Aids alignment of multifunctional activities across multiple research studies such that programs progress in a satisfactory manner. Responsibilities include strategic planning, communications, pre-award and post-award review of projects to determine assignment of necessary resources; coordination of personnel and other resources across multiple projects; adherence to regulatory requirements for human subjects research; and development/maintenance of timely and meticulous recordkeeping systems. Responsibilities: I. Programmatic and Strategic Planning: Lead regular Leadership meetings to develop the lab vision, future development, technical conception, goal and objective setting, priority setting, and strategic planning. Oversee financial forecasting across funding sources for strategic planning and to ensure alignment of fiscal and human resources with specific project objectives and overall lab resources. Develop periodic plans to align lab and University resources to achieve faculty research goals. Cultivate an understanding of appropriate performance indicators as relevant for a variety of funding sources. Work with lab staff to develop, promote, maintain, and evaluate best practices. Ensure that contractual and programmatic goals and objectives are met and assure that performance is well-documented and communicated to funders and other stakeholders. Identify opportunities and potential threats to lab programs; analyze and resolve emergent issues, interface with appropriate colleagues and partners as well as existing University systems and practices; recommend and implement solutions. Work closely with University Risk Management to assure the safety and security of staff and assets in foreign locations, as applicable. Provide excellent management and organizational skills; ability to manage program initiation and change, manage for results, and apply keen decision-making skills. Guide lab Investigators and staff in establishing quality standards to planning and implementing lab programs, including data monitoring and evaluation, quality assurance, training activities, and technical assistance to support program implementation, evidence-based program decision-making, and reporting results in a timely fashion. Model superior leadership and team-building skills. Coordinate and provide support for external meetings (e.g., Investigator meetings). Organize and lead cross-functional teams as necessary. II. Financial and budget management: Actively participate in the development of annual budgets, proposal budgets, and spending plans. Actively participate in the review of financial reports. Interpret, analyze, and make recommendations to ensure ongoing spending plans appropriately support overall Schmitz lab strategic goals. Ensure appropriate administrative and budget policies to ensure compliance with University, state, and federal regulations. III. Personnel Administration/Human Resources: Manage the human resource functions for the faculty and staff within the Schmitz lab. With the PI and applicable faculty, oversee hiring processes, salary negotiations, conflict resolutions, and manage the organizational structure of the Schmitz lab. Work with team leads to develop core competencies and job responsibilities for staff, including position descriptions, expectations, and performance management. IV. Regulatory Affairs Management: Plan appropriate communications with regulatory authorities including, but not limited to, the FDA, IRB/ERCs, national regulators, ministries of health, and other governing bodies as applicable. Oversee and ensure compliance with fiscal policies and procedures, inclusive of sponsor, federal, state, and/or other funding sources. Implement effective regulatory strategies addressing regulatory submission and responses. Develop and oversee document control system. Supervise regulatory affairs staff. V. Research Protocol Development and Data Management: In collaboration with the PI and research faculty, manage the development of research protocols and case report forms. Direct clinical data management activities including acquisition/collection, data abstraction/extraction, processing and coding, preparation of analytic data sets, data storage, privacy, and quality assurance. Oversee that data operations are managed in compliance with GCP and GDMP (Good Clinical Practice and Good Data Management Practice). Supervise Schmitz Lab protocol coordination and data management personnel. VI. Specimen Repository Operations Management: Direct the day-to-day management of the specimen repository. Collaborate with Schmitz Lab Leadership to establish and manage longer term priorities. Supervise the Specimen Repository Manager. VII. Quality Assurance: Develop and direct a Schmitz Lab quality program, including: cultural competency and community engagement, clinical research monitoring, specimen repository monitoring, and other parameters of compliance and performance. Liaise with external regulatory bodies as needed such as the Centers for Disease Control. VIII. Research Operations Oversight: Serve as adviser on operational tools and systems employed within the Schmitz lab studies. Supervise the team of Research Coordinators who are responsible for the implementation of operational and regulatory aspects of the laboratory studies. REQUIREMENTS: Master’s Degree in Science, Public Health, Business, or related field plus a minimum of 10 years of experience in clinical research with 5 in a supervisory role. Additional Requirements: Strategic and tactical excellence at the finance and operational manager level in a large, complex organization. Proven project management skills. Self-motivated, resourceful with strong organizational skills and able to multi-task and work collaboratively in large, complex, multi-departmental, cross-functional, cross cultural teams effectively. Demonstrated ability to complete tasks with high quality and in a timely fashion, identify problems and possible solutions and assess the impact on timelines. Diplomacy, excellent judgment, proven ability to communicate effectively and present site performance and contract research organization performance for internal review. Excellent written and oral communication skills. Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration. DESIRED: Experience in the conduct and management of large scale clinical trials. Proficiency in Good Clinical Practices (GCP) and international regulatory requirements. Relevant experience working with diverse and minority populations is highly desirable. Professional experience managing FDA-regulated trials and the requisite procedures and report submission.
These salary bands have been established to provide salary guidelines for staff positions.