Primary point of contact for Pharmaceutical Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients (sites, vendors, ancillary departments). Works with clinical group to ensure integrity of the clinical data and Investigator compliance with protocols. Ensures that the clinical trials are performed under GCPs.
Key Responsibilities Include:
Overall management of global Phase III/III studies within various indications and/or therapeutic areas
Provides strategic operational direction to study teams to meet corporate study goals and timelines
Manage and monitor tasks and timelines of internal and external resources to achieve program objectives
Participates in the selection of Contract Research Organizations (CROs). May attend CRO or other vendor meetings such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals
Provides consistent, regular oversight of CRO and vendor performance including monitoring and site management; co-monitoring of assigned CRAs as needed
Contributing member of various study and program teams; provides direction to junior staff in creating meeting agendas and documenting outcomes and deliverables
Oversight of vendor budgets and contracts, in conjunction with Finance department
Ensure studies are conducted under GCP and ICH Guidelines
Obtain and review all pertinent study documents from the CRO for study initiation and continuation
Obtain and review site visit reports from monitor(s) to determine potential study conflicts
Participate in the writing and review of clinical SOPs
Travel may be required up to 25% in support of clinical study activities
Reporting and justification of study metrics to senior and executive management
Typically requires a minimum of 8-10 years of related experience or a minimum of 12 years combined education/training and experience.
Experience in Biotech/Pharmaceutical industry preferred.
Management experience including outsourcing to Contract Research Organizations (CROs).
Knowledge of FDA regulatory requirements
Position can be remote if necessary.
Additional Salary Information: Bonus
About Trevi Therapeutics
Trevi Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing Nalbuphine® ER for chronic pruritic conditions. Pruritus develops in various dermatologic, metabolic, hematologic, and neuropathic conditions. The Company is pursuing two conditions for clinical development: uremic pruritus and prurigo nodularis. Uremic pruritus is a persistent and debilitating itch in patients on dialysis that has been associated with significant impairment in quality of life and increased mortality. Prurigo nodularis is an intensely pruritic dermatologic condition characterized by unsightly and itchy skin papules and nodules. There are no approved therapies in the United States or Europe for either condition.