Developmental Therapeutics Project Director

Position Summary 

All staff are employed through the Research Foundation. This role will be in service to COG.

The Developmental Therapeutics Project Director will be responsible for the project administration and management of early phase trials with a cadre of COG operations teams, study teams, COG and PEP-CTN leadership, PhD statisticians, and league directors.  They will ensure that study development, implementation and conduct of early phase clinical trials are developed and implemented within sponsor specified timelines. They will also monitor study progress, oversee site performance and data quality, and ensure reporting and presentation/manuscript development in a timely manner.

The Developmental Therapeutics Project Director will serve as the Pediatric Early Phase Clinical Trial Network (PEP-CTN) Operations Statistics and Data Center (ODSC) Director maintaining a reporting relationship with the PEP-CTN grant Principal Investigator for grant operations management, grant objective oversight reporting, and grant renewals. The position will manage the Developmental Therapeutics Project Coordinator. The Developmental Therapeutics Project Director will report to the Executive Director of Data Operations and will be a member of the COG and PEP-CTN leadership team and provide valuable consultation on organizational decisions.

The position will work in conjunction with Industry Sponsored Trials (IST), Administration and Finance, PEP-CTN leadership, study teams, and the other teams in COG Research Foundation, LLC in developing and managing the terms of contracts and agreements as they relate to early phase investigational agent trial operations.

The COG Research Foundation, LLC is a 100% remote employer, though some travel may be required.  Employee must reside within the United States.

Full salary range for this position: $131,732 to $204,009 per year. The typical hiring range for this position is from $131,732 (minimum) to $167,871 (midpoint), based on 100% FTE. The starting salary is determined based on the candidate’s knowledge, skills, experience, as well as budget availability.

Essential Duties and Responsibilities

Serve as PEP-CTN Operations and Data Center (ODSC) Project Director

• Perform grants administration and management as it relates to the Pediatric Early Phase Clinical Trial Network (PEP-CTN) grant and any supplements awarded in conjunction with the prime award.
• Oversee and report on progress towards grant aims and objectives, throughout the year.
• Develop and manage overall grant budget in excess of $3,000,000 annually in collaboration with Financial Integrity & Resource Management and Grants Administration departments.
• Partner with Contracts Management and Grants Administration departments to ensure that subawards are issued to all relevant institutions for work performed under the grant.
• Manage enrollment and milestone reports for per case reimbursement and other funding milestones with Financial Integrity & Resource Management and Grants Administration departments to ensure timely payments.
• Author annual grant progress reports and progress summaries for competitive and non-competitive grant renewals.
• Oversee and manage PEP-CTN member institution performance assessments including bi-annual assessment, recompetition, suspensions, and terminations.
• Develop and maintain the PEP-CTN standard operating procedures while ensuring alignment, consistency, and effective implementation.
• Lead and manage the development and required reviews of early phase trial abstracts and publications, within grant required timelines and ensuring appropriate acknowledgements.

 Oversee clinical trial planning and implementation activities for industry related early phase trials, including fully industry sponsored trials.

• Oversee the development of all clinical trials assigned to the developmental therapeutics, early phase portfolio, including fully industry sponsored collaborations.
• Lead and partner with appropriate study committee members and COG core resources to guide the execution of clinical trials, ensuring alignment with program objectives, regulatory requirements, and timely development and implementation of clinical trials.
• Proactively identify solutions to barriers to study development or implementation of early phase studies.
• In collaboration with Industry Sponsored Trials Senior Director, serve as a key operational contact for industry sponsors during the planning and conduct of early phase trials.
• Establish and oversee quality assurance plans, targets and metrics for early phase trial teams (e.g. accuracy, timeliness, reliability, productivity) in alignment with the matrix organization. Regularly review and measure progress against goals. Proactively address challenges.

Develop a positive and proactive team culture and foster effective relationships with other COG and PEP-CTN leaders, staff, COG Members and institutions.

• Develop and maintain collaborative relationships and approaches with COG and PEP-CTN leadership.
• Work collaboratively with COG and PEP-CTN leadership to develop a high functioning team-based environment. Maintain professional and effective communications and proactively resolve challenges.
• Alongside other COG and PEP-CTN leaders, develop and implement organization-wide process improvement initiatives.
• Build a culture of trust and teamwork among teams and team members.
• Lead through example, upholding the mission and purpose of COG and the PEP-CTN.
• Supervise, mentor, and coach direct reports and team members, fostering professional development, growth, and sustained high performance across the team.

Lead and perform administrative tasks and participate in other COG and PEP-CTN activities as required, including but not limited to:

• COG or PEP-CTN educational and training activities.
• Study specific budget development and preparation, implementation, and analysis.
• Meeting planning and coordination.
• Perform other duties as assigned

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

Minimum Qualifications

• Eight (8) years of experience in clinical trial operations trials, including research grant administration experience or related experience, and at least four (4) years of management level experience. Knowledge/experience related to leadership can substitute.
• Bachelor’s degree in Health Care Administration, Science, or related field or substitute with four (4) additional years of related experience.

Other Qualifications

• Excellent interpersonal skills and demonstrated ability to supervise and manage staff.
• Proven experience in managing multiple projects within a multi-site network.
• Must be familiar with essential FDA regulations governing clinical trials and Investigational New Drugs.
• Experience in federal grant progress reporting via eRA commons highly desired.
• Excellent written and oral communications skills. 
• Goal/results oriented with proactive approach to problem-solving.

 Preferred Qualifications

• Experience in electronic data capture (EDC), database design, development and implementation is highly desirable. Medidata Rave experience preferred.
• Experience in clinical data operations in a comprehensive cancer center, a cooperative group or the pharmaceutical/biotechnology industry is highly desirable.
• Ten (10) years of experience in clinical trial operations trials, including research grant administration experience or related experience.
• Project management certification.

Fair Labor Standard Act (FLSA) Status

This position is classified as exempt based on the job duties. However, based on the FTE, salary level of the employee, or federal/state/local laws, the employee may be classified as nonexempt.