Sionna Therapeutics
Sionna Therapeutics is a clinical‑stage biopharmaceutical company on a mission to revolutionize the treatment of cystic fibrosis (CF) by developing novel medicines that normalize CFTR protein function. Leveraging more than a decade of research on CFTR’s nucleotide‑binding domain 1 (NBD1), the company is advancing a pipeline of small molecules designed to correct the F508del mutation and work synergistically with other CFTR modulators to improve clinical outcomes and quality of life for people with CF.
Base pay range $200,000.00/yr - $235,000.00/yr
Position Summary Director of Clinical Operations
– work collaboratively with the co‑Director of Clinical Operations, internal teams, external vendors, and key stakeholders to support clinical trials and ensure compliance with regulatory standards. This leadership role oversees all aspects of clinical operations across multiple programs, driving studies through all phases of clinical trials (Phase I‑III) and managing clinical teams, budgets, and vendor relationships.
Responsibilities
Lead and mentor the clinical operations team, providing operational strategies to achieve corporate, program, and departmental goals.
Develop and coordinate operational plans for clinical studies, including site selection, initiation, and enrollment.
Oversee CRO and vendor selection, contract negotiation, budget planning, and adherence to budgetary targets.
Evaluate and communicate vendor performance, proactively managing issues and solutions.
Ensure regulatory compliance (ICH, FDA, EMA, etc.) and GCP adherence.
Prepare and review clinical documents such as protocols, informed consent forms, investigational new drug applications, and clinical study reports.
Manage investigator and site identification, activation, and enrollment against established targets.
Oversee third‑party vendor management and coordinate QA audit processes.
Support site management in alignment with ICH/GCP standards and SOPs.
Collaborate with the Head of Clinical Development Operations to define best practices and Processes for the Clinical Operations team.
Provide regular study updates, anticipate and communicate operational risks, and develop contingency plans.
Mentor and evaluate team members, facilitating staff development.
Stay current with therapeutic area knowledge to ensure best practice across all activities.
Build relationships with internal and external stakeholders to facilitate trial planning, execution, risk management, and mitigation.
Perform additional tasks and responsibilities as required.
Requirements
Bachelor’s degree or equivalent (health‑related field preferred).
10+ years of experience in the pharmaceutical/life‑science industry, with significant global clinical operations experience.
8+ years of experience managing teams.
Proven track record in clinical site selection, initiation, management, and enrollment.
Strong understanding of how study‑related decisions impact other functions and deliverables.
Knowledge of drug development and project management from pre‑IND through NDA.
Expertise in global regulatory and compliance requirements for clinical research, including US CRF, EU CTD, and ICH GCP.
Experience working in cross‑functional, team‑oriented environments.
Excellent communication skills, both written and verbal, with a track record of keeping stakeholders informed of status, issues, and solutions.
Strong organizational and project‑management skills, capable of working independently.
Adaptability to changing priorities and fast‑paced environments in a small organization.
Benefits
Medical insurance
Vision insurance
401(k) plan
Disability insurance
Paid maternity leave
Paid paternity leave
Location: Boston, MA
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Base pay range $200,000.00/yr - $235,000.00/yr
Position Summary Director of Clinical Operations
– work collaboratively with the co‑Director of Clinical Operations, internal teams, external vendors, and key stakeholders to support clinical trials and ensure compliance with regulatory standards. This leadership role oversees all aspects of clinical operations across multiple programs, driving studies through all phases of clinical trials (Phase I‑III) and managing clinical teams, budgets, and vendor relationships.
Responsibilities
Lead and mentor the clinical operations team, providing operational strategies to achieve corporate, program, and departmental goals.
Develop and coordinate operational plans for clinical studies, including site selection, initiation, and enrollment.
Oversee CRO and vendor selection, contract negotiation, budget planning, and adherence to budgetary targets.
Evaluate and communicate vendor performance, proactively managing issues and solutions.
Ensure regulatory compliance (ICH, FDA, EMA, etc.) and GCP adherence.
Prepare and review clinical documents such as protocols, informed consent forms, investigational new drug applications, and clinical study reports.
Manage investigator and site identification, activation, and enrollment against established targets.
Oversee third‑party vendor management and coordinate QA audit processes.
Support site management in alignment with ICH/GCP standards and SOPs.
Collaborate with the Head of Clinical Development Operations to define best practices and Processes for the Clinical Operations team.
Provide regular study updates, anticipate and communicate operational risks, and develop contingency plans.
Mentor and evaluate team members, facilitating staff development.
Stay current with therapeutic area knowledge to ensure best practice across all activities.
Build relationships with internal and external stakeholders to facilitate trial planning, execution, risk management, and mitigation.
Perform additional tasks and responsibilities as required.
Requirements
Bachelor’s degree or equivalent (health‑related field preferred).
10+ years of experience in the pharmaceutical/life‑science industry, with significant global clinical operations experience.
8+ years of experience managing teams.
Proven track record in clinical site selection, initiation, management, and enrollment.
Strong understanding of how study‑related decisions impact other functions and deliverables.
Knowledge of drug development and project management from pre‑IND through NDA.
Expertise in global regulatory and compliance requirements for clinical research, including US CRF, EU CTD, and ICH GCP.
Experience working in cross‑functional, team‑oriented environments.
Excellent communication skills, both written and verbal, with a track record of keeping stakeholders informed of status, issues, and solutions.
Strong organizational and project‑management skills, capable of working independently.
Adaptability to changing priorities and fast‑paced environments in a small organization.
Benefits
Medical insurance
Vision insurance
401(k) plan
Disability insurance
Paid maternity leave
Paid paternity leave
Location: Boston, MA
#J-18808-Ljbffr