Director, Clinical Operations - Tempero Bio

Company Overview

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.  The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.

Position Summary

The Director of Clinical Operations will contribute to the execution of clinical development plans and the development of clinical trial strategy, lead the operational aspects of clinical trials from start to finish, including vendor selection and oversight. The Director of Clinical Operations will leverage a deep understanding of clinical trial operations, regulatory requirements, and industry best practices to ensure high quality study execution and within the established timelines and budgets.

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Position Responsibilities

• Conduct new clinical trial planning activities including operations strategy, budget and milestone development, vendor identification.
• Contribute to CRO and site engagement, evaluation, and contracting processes.
• Lead internal project plan and other study specific plans development, including but not limited to timeline, risk log, and vendor oversight.
• Manage cross-functional study inputs, review and approval activities.
• Lead the interactions and management of CRO and other vendors from startup to the end of the contracted engagement, with accurate tracking and reporting of study progress and metrics.
• Function as the CRA manager to oversee all aspects of monitoring activities on studies that are monitored by Aditum Bio.
• Ensure quality, compliance, and timeliness of all deliverables.
• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports
• Contribute to SOPs, standards, and technology development.

 Qualifications

• BS or BA Degree required, in a science or health related field. Advance degree preferred.
• Minimal 10 years experience biotech/pharma/CRO clinical trials experience with at least 6 years hands-on end-to-end clinical project management experience.
• Experience in Neuroscience and Immunology preferred.
• Experience in early phase clinical trials including Phase II studies preferred.
• Experience with both in-house operational model and outsourced model preferred.
• Experience with clinical operations applications, eCOA and DCT preferred.
• 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.
• Strong organizational skills and demonstrated ability to develop positive working relationships with internal and external organizations and stakeholders.
• Results-oriented, motivated, and flexible.

 

The range for this full-time position is $225,000 - $235,000, plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.