AD of Clinical Operations at Goldfinch Bio
Cambridge, MA, US
The Role

The Director of Clinical Operations and Development will play a key role to manage, plan, and execute clinical development programs and studies, including creating and managing study timelines, budgets, and study management plans. Additionally, s/he will provide guidance and shared learning with and across teams throughout planning and implementation, as well as ensure clinical operational and development deliverables and timelines are met across the development program(s). This position will report to the Vice President, Clinical & Translational Nephrology.

Major Responsibilities

Responsible for the infrastructure build and creation of process for early-stage clinical development
Lead the evaluation, selection and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation and execution
Create, manage, and execute clinical operations and development programs, including study management, budget and timeline creation
Manage and lead CRO’s
Ability to build strong KOL, Principal Investigator relationships, and CRA’s with the ability to easily understand and explain complex scientific topics
Lead program development teams, and understand the intricacies among the different cross-functional groups, including medical affairs, HEOR, and other late-stage teams
Participate with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
Develop and ensure execution of activities outlined in various study plans (data management, safety management, and study communication plans)
Participate in preparation of regulatory filings (e.g. IND, pre-IND, orphan applications etc.) as needed
Partner with CMC/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
Manage all aspects of study progress from planning to close-out to assure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
As appropriate, Lead, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings as needed
Attend scientific conferences as needed
Requirements and Qualifications

Master’s Degree Preferred
5 years of Clinical Operations experience within a sponsor company
Experience in All phases of development: HV, Phase 1-3, adaptive designs
Experience running programs in EU and the US
Must have rare disease experience and conducted First in Human Studies
Nephrology Therapeutic Area experience strongly preferred
Robust understanding and experience leading early-stage clinical development programs, including proof-of-concept, Phase 1, Phase 2, and through later development.
Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient
Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
Understanding of drug development and program management from pre-IND through NDA
Extensive experience managing late-stage clinical programs, CROs, budgets, and timelines
Strong working knowledge of MS Project and developing Gantt charts
Experience monitoring clinical studies and conducting PSVs, SIVs, IMVs, and COVs required.
Management of CROs, multiple vendors, and complex protocols
A detailed understanding of overall strategic direction, interrelationships and business needs.
Proven experience in the oversight of the operational aspects of all stages of clinical studies

If you would like to be considered for an opportunity at Goldfinch Bio, please submit your CV with the title of the position in the subject line.