Job Title: Vice President, Clinical Operations and Data Management
Job Number: 25053
Location: 215 First Street 4th Floor Cambridge, MA 02142
Goldfinch Bio is seeking a highly motivated, patient-focused, results-oriented leader for our growing Clinical Operations and Data Management organizations. The selected candidate will ensure excellence in clinical trial planning, execution and data collection, in accordance with associated regulatory guidelines. They will be responsible for all aspects of clinical study conduct including site selection, contract negotiations, budget management, study start-up, conduct and real time data delivery, providing leadership and resolution of trial and/or program specific issues to deliver high-quality clinical trial results.
The position will be based in Cambridge, Massachusetts, and reports to the Chief Development Officer.
- Responsible to build and lead clinical operations and data management including building the resources and creation of processes for early-stage clinical development
- Assess and implement innovative clinical trial and data management approaches
- Lead the evaluation, selection, and management of Contract Research Organizations (CROs) and other external vendors to ensure successful clinical trial implementation, execution and data collection
- Develop, propose, and implement clinical operations strategy, including budget, enrollment models and timeline creation for each program and indication.
- Partner closely with clinical, regulatory, biostatistics and pharmaceutical development leadership to design, plan and execute on effective clinical trial designs.
- Identify program risks and develop and implement mitigation strategies for all pipeline programs.
- 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, end of Phase 2 meetings, orphan applications etc.) as needed
- Partner with pharmaceutical development/clinical supplies to provide drug supply assumptions and contribute to design and packaging of supplies for clinical trials
- Champion and support the development and implementation of Quality Management Systems and GxP processes, in collaboration with regulatory/quality leadership
- As appropriate, plan, and execute clinical Investigator meetings, study meetings, and vendor meetings.
- A minimum of a bachelor’s degree, with masters degree preferred, in a scientific or health related field
- 15+ years of relevant experience in a Clinical Operations function with appropriate oversight and/or experience in data management, including 3+ years in a leadership role within a sponsor company
- Experience overseeing and completing complex clinical studies, including rare disease studies and trials with biomarker readouts. Phase 1 and 2 experience necessary including IND filings, with experience in late stage clinical development a strong plus.
- Experience running programs in US and the EU
- Nephrology Therapeutic Area experience strongly preferred
- Experience in effectively managing CROs
- Excellent working knowledge of the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) Guidelines and other applicable regulatory regulations and guidelines
- Strong attention to detail and creative problem-solving skills are essential
- Evidence of commitment to innovation and patient-centricity
- Ability to work independently and in a highly collaborative innovative team environment while remaining flexible, proactive, resourceful and efficient
- Ability to travel as needed to various CRO’s and clinical testing sites