Associate Director/Director, Global Clinical Operations at Vor Bio

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Experience and knowledge of end-to-end management of clinical trial operations
Knowledge of the pharmaceutical industry
Understanding of clinical drug development and clinical trials operations

Responsibilities

Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with a focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives
Ensure clinical trials comply with ICH/GCP guidelines, regulations, and company SOPs
Develop operational strategy and clinical operations plans to support the execution of the Clinical Development Plan
Support the selection, oversight, and management of CROs and other vendors
Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team
Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports, and other documents and plans as appropriate
Manage the cross-functional team and CRO/vendor(s) related to all aspects of clinical trial operations
Assist in forecasting clinical trial material and ancillary supplies
Represent Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensure compliance with operational standards and procedures
Ensure timely review of protocol deviations and assess the impact on study data
Represent Vor Biopharma externally to Investigators, site staff, and Key Opinion Leaders
Perform and document study level Sponsor Oversight of outsourced clinical activities
Communicate study status, cost, and issues to ensure timely decision-making by senior management
Oversee/collaborate and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct
Develop and foster strong, collaborative relationships with key stakeholders both within and external to Vor Biopharma
Support program level deliverables/activities

Skills

Clinical Operations

Clinical Trials Management

CRO Management

Vendor Management

Cross-Functional Collaboration

Pharmaceutical Industry

Autoimmune Programs

Clinical Development

Trial Execution

Global Clinical Operations

Vor Bio

Develops targeted therapies for blood cancers

About Vor Bio

Vor Biopharma focuses on developing treatments for blood cancers, particularly Acute Myeloid Leukemia (AML). Their approach is designed to protect healthy cells while specifically targeting and eliminating cancerous cells. This method aims to improve the effectiveness of blood cancer treatments. Vor Biopharma serves patients with blood cancers, their caregivers, and medical professionals in hospitals and oncology centers. What sets Vor Biopharma apart from competitors is their strong emphasis on research and development, investing significantly in scientific research to create a proprietary platform and pipeline of therapies. They generate revenue through partnerships with other pharmaceutical companies and licensing agreements, with the goal of commercializing their therapies after obtaining regulatory approval. The company's mission is to transform the treatment landscape for blood cancers by providing innovative therapies that prioritize patient safety and efficacy.

Cambridge, MassachusettsHeadquarters

2015Year Founded

$147.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees