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Hemab Therapeutics · 16 hours ago

Associate Director Clinical Operations

Cambridge, MA

Full-time

Onsite

Lead/Staff, Director/Executive

9+ years exp

Hemab Therapeutics is a clinical-stage biotech company focused on developing treatments for neglected bleeding and thrombotic disorders. As the Associate Director of Clinical Operations, you will lead the planning, implementation, and oversight of clinical studies, ensuring that timelines and operational deliverables are met while managing cross-functional teams.

BiotechnologyLife ScienceMedicalPharmaceutical

Responsibilities

Serve as the subject matter expert within clinical operations for the planning and execution of studies across all phases

Work cross-functionally to ensure clinical program timelines and goals are met and risks are appropriately escalated

Develop, review, and/or consult on clinical trial documents such as informed consent, clinical protocols, Investigator Brochure, yearly updates to the regulatory authorities and status updates

Manage CRO study team(s), clinical sites, laboratory vendor(s), and other outsourced work on assigned studies to ensure consistency of methods, interpretation, and approach with other Hemab-sponsored studies

Communicate regularly to stakeholders on program/trial status, tracking to goals, risks, and mitigations

Manage the clinical trial budget and provide financial reporting and projections as needed

Operationalize and execute the Clinical Development Plan (CDP)

Ensure trial adherence to ICH/GCP, federal and local regulations, and company specific SOPs

Effectively evaluate qualified study sites, oversee monitoring activities, and support clinical site initiation visits, co-monitoring, and close-out visits as needed

Assess study drug requirements and shipment and supply logistics, contributing to pharmacy manual

Maintain tracking for study metrics that are essential to managing the study closely (patient visit information, data entry, monitoring, and data cleaning information, etc.)

Oversee TMF filing and QC activities as needed

Mentorship and line management of direct reports

Qualification

Clinical trial managementCross-functional project managementICH/GCP regulationsEarly phase trialsRare disease experienceLine managementVerbal communicationWritten communicationIndependent work

Required

Bachelor's Degree in life sciences or healthcare discipline

At least 9 years of clinical trial management experience and at least 2 years managing cross-functional project teams

Direct experience conducting early phase trials

Working knowledge of ICH/GCP regulations and guidelines

Solid understanding of cross-functional areas, including data management/biostatistics, regulatory affairs, and pharmacovigilance

Proven verbal and written communication skills; enjoys interacting with others regularly

Able to prioritize tasks and work independently

Able to travel an average of 20-30%, both domestically and internationally

Line management experience

Preferred

Monitoring experience preferred

Experience in rare disease or orphan drug development preferred, with demonstrated understanding of unique challenges in patient recruitment, regulatory pathways, and engagement with specialized centers