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Director, Trial Management

Position Summary:

At Aditum Bio our mission is to give patients access to medicines that may not otherwise be developed. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis, and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. Aditum Bio focuses on the translational phase of medicine (Phase I and Phase II) to generate data that can support full clinical development, and eventual market launch, to reach patients in need. We in-license these new therapies and incubate new companies that then develop and operate these drugs through early-stage clinical trials. 

We are currently seeking a Director of Trial Management who will report directly to the VP of Clinical Operations of our fast-paced, exciting, and growing organization. This is a unique opportunity for a creative, outcome-oriented trial manager to support the early-stage development of an addiction treatment.   

Position Responsibilities:

  • Successfully manage and execute clinical trials and programs.

 

  • Navigate clinical trial interdependencies to minimize timeline impacts.

 

  • Ensure quality, compliance, and timeliness of all deliverables.   

 

  • Establish and monitor all project activities for adherence to plan and serve as the key contact for assigned projects as well as the escalation point for internal and external stakeholders.

 

  • Drive and oversee vendors, including CROs. Participate in selection of CRO and vendors including development of RFPs, budget negotiations and management.

 

  • Author, audit and/or edit written summaries of data reports, presentations, and training manuals.

 

  • Participate in protocol design, CRF and strategy development, Clinical Study Report (CSR) preparation, NDA submissions, as appropriate.

 

  • Establish program milestones and ensure accurate tracking and reporting of study/program metrics and timelines.

 

  • Provide regular verbal and dashboard updates to leadership and teams regarding the status and progress of the projects.

 

  • Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports

 

  • Draft internal study specific plans and edit CRO study plans.

 

  • Ensure adherence to GCP, regulations and applicable procedures, in addition to protocol compliance.

 

  • Mentor and train team members.

 Qualifications: 

  • BS or BA Degree required, in a science or health related field strongly preferred.

 

  • At least 6-7 years of clinical research experience.  

 

  • Experience with psychometric scale management is strongly preferred.

 

  • Experience leveraging ePRO for optimal patient experience and data quality.

 

  • Demonstrated ability to develop positive working relationships with internal and external organizations and stakeholders.

 

  • Demonstrated core understanding of medical terminology and clinical trial activities as it relates to the execution of a clinical development plan. Excellent understanding and working knowledge of clinical research, phases of clinical studies, current ICH GCP & country clinical research law & guidelines.

 

  • Proficient understanding of R&D processes including the principals of study design and execution; knowledge of industry standards and practices.

 

  • Experience in running a clinical trial from start to finish, initiating the trial the includes protocol writing, contract and budget negotiation, vendor management, etc.

 

  • Results-oriented, motivated, and flexible.

 

  • Strong skills in deviation evaluation and CAPA implementation.

Company Overview:

 

Aditum Bio is a new model of biotech venture capital uniquely positioned to rapidly translate scientific discoveries into innovative new medicines. Aditum brings together unmatched scientific and domain expertise, combined with operational capabilities. Our agile operating model enables rapid company formation, planning, and execution for a new model of drug development. We target clinic-ready therapies to help underserved patient populations, rapidly forming companies and staffing them with medical and scientific experts. Launched in 2019 by former Novartis CEO Joe Jimenez and former President of the Novartis Institutes for BioMedical Research, Dr. Mark Fishman, Aditum currently manages a broad portfolio of clinical stage companies with multiple drug candidates entering Phase 2 clinical trials in 2022.

Aditum Bio provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.