Head of Clinical Operations

Head of Clinical Operations (Director – VP level)

Affinia Therapeutics is biotech company developing transformative gene therapies for devastating cardiovascular and neurological diseases. We are backed by a strong syndicate of life science investors and have ambitious plans to have a dramatic impact on the lives of patients around the world. The pace of work is dynamic, fast and fun.

We are looking for a curious, organized and self-motivated individual to join our team at Affinia. Team members work together across functions for a common purpose. This is an excellent opportunity to gain experience and develop in a dynamic, next-generation gene therapy environment.

We offer competitive salary and benefits with the ability to make a difference.

Position Summary

Reporting to the Chief Medical Officer, you will partner closely with cross functional leadership to drive the U.S. and global clinical operations strategy and implementation for Affinia Therapeutics. As the Head of Clinical Operations, you will be capable of planning and executing early-stage clinical trials (First-in-human Phase 1 and Phase 2). The candidate will interface with internal and external stakeholders to plan, execute and problem solve before and during the life of clinical trials, initially in rare cardiac indications. The candidate will focus on clinical trial site-, Contract Research Organization (CRO)-, and patient-facing interactions to ensure smooth execution of studies, including start-up, drug and budget forecasting, and acquisition of detailed, high-quality clinical (including safety and efficacy) and translational data to support evaluation of the therapeutics under study. The candidate will be clear and efficient in communicating with cross-functional team members to achieve these goals.

This position is located at the Affinia Therapeutics site in Waltham, MA with 4 days per week (M-Th) in the office.

Primary Responsibilities

• Develop our clinical operations strategy for cardiac gene therapy agent(s) in development, either directly or by leading trial staff depending on the stage of the pipeline.
• Cross-functional collaboration to develop needed outputs such as protocols, annual safety reports and investigator brochure, clinical trial reports, presentations, regulatory submissions, and publications.
• Evaluate external collaborators including Contract Research Organizations (CROs) and trial sites and select the best candidates for each needed function. Develop vendor scope of work, contract, quality, monitoring, and budget.
• Develop and lead patient finding and recruitment strategy, planning, and forecasting.
• Develop and manage standard operating procedures (SOPs) for the organization and its external collaborators. Ensure GCP (Good Clinical Practice) compliance.
• Continuously evaluate performance of external collaborators and vendors, troubleshoot and recommend a path forward when challenges are encountered.
• Develop and manage study timelines, working with internal partners (including but not limited to clinical development, translational, CMC, regulatory affairs, and project management).
• Attend and, where appropriate, present at trial site initiation meetings and calls.

Qualifications

• Minimum 8-10 years of experience in clinical operations, including rare diseases and/or cardiology
• Experience managing Phase 1 dose-finding trials
• Experience leading patient-finding initiatives, especially those requiring genetic testing, to support clinical trial enrollment
• Experience managing CROs and vendors both in the U.S. and in international clinical trials
• Experience in trial site initiation visits, site management, data cuts for publication and regulatory requirements
• Understanding of the drug development process from IND to NDA/BLA
• Dedication to collaborative work in a fast-paced environment; open-mindedness to shifting strategy in a data-guided manner
• Ability to communicate effectively and efficiently and willingness to train other team-members within and outside of Clinical Operations
• Degree in a relevant discipline
• Experience in Cardiology preferred
• Experience in Gene Therapy preferred
• Experience with small population indications (e.g., rare disease or cardiology) preferred

Equal Opportunity Employer

Affinia is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.