Lead clinical trial execution across the site network, overseeing study start-up, activation, and ongoing operational performance.
Serve as the primary operational liaison for Sponsors and CROs, providing regular updates on study progress, risks, and mitigation strategies.
Act as a central resource for site teams, resolving operational and protocol-related challenges and driving timely solutions.
Hawthorne Health is a leading community site network and home research visit solution provider, with 20+ sites and more than 2,000 research experienced healthcare professionals across the U.S. They leverage convenient, trusted, healthcare locations, identified patient data, and intelligent technology to accelerate patient access, improve retention, and reduce study costs.
Act as Local Contact Person for Pharmacovigilance for the designated country.
Assume leadership and functional representation for projects of medium/high complexity ensuring effective and rapid coordination and management of regulatory deliverables.
Foster professional working relationships with internal and external contacts at the local and international levels to ensure smooth and efficient service delivery.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They provide first class support to their small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field.
This position supports the Clinical Trial Patient Safety organization in evaluating and ensuring the quality of clinical trial patient safety data.
Responsible for world-wide surveillance of clinical trial patient safety data, including organization, resourcing, and continuous improvement efforts.
Manages assigned operational area(s)compound associated clinical studies and related systems to ensure clinical safety adverse event surveillance is managed in a compliant and timely manner.
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. They strive to have a remarkable impact on people’s lives across several therapeutic areas including immunology, oncology and neuroscience.
Leads the Clinical Study Team for assigned projects from concept to protocol.
Manages external vendors and contract research organizations.
Manages operational activities at the study level and monitoring activities at clinical study sites to assure adherence to GCP, SOPs, and study protocols.
BridgeBio is committed to discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases with unmet needs. They build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.
Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
Prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
Lead study start-up/maintenance: prepare and submit all required regulatory documents for new/current study applications and successfully open/close studies from inception to accrual.
Emory University is a leading research university fostering excellence and attracting world-class talent to innovate today and prepare leaders for the future. They welcome candidates who can contribute to the excellence of their academic community.
Serve as Global Regulatory Lead for the Phase 3 HCM program.
Provide strategic regulatory input and leadership at program governance forums and core team meetings.
Plan, prepare, review, and oversee submissions to regulatory authorities supporting late-stage development and registration readiness.
Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. With a proven leadership team, a strong financial foundation, and a high-value late-stage asset, they represent an outstanding opportunity for ambitious, mission-driven professionals.
Manage site start up through activation readiness strategy and oversight of site start up delivery.
Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations and Contract Execution.
Collaborate and communicate with stakeholders to secure input for milestone planning and alignment of operational goals.
Precision for Medicine is a Clinical Research Organization with an integrated offering that enables precision medicine by combining clinical trial designs, experts, biomarker and data analytics solutions. They focus on rare diseases and oncology, in addition to other therapeutic areas.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Collaborate with client teams to understand products and create regulatory strategies.
Implement strategies by engaging regulatory authorities and authoring submissions.
Proactively influence the regulatory environment to achieve business goals.
EVERSANA provides next-generation commercialization services to the life sciences industry, serving over 650 clients from biotech startups to established pharmaceutical companies. They have a global team of more than 7,000 employees committed to creating a healthier world by bringing innovative therapies to market and supporting patients.