JOB TITLE: Vice President of Biostatistics LOCATION: Boston MA JOB SUMMARY: Seeking an accomplished and highly experienced Vice President of Biostatistics to lead our biostatistics team. The ideal candidate will possess a deep understanding of biostatistics in the context of oncology drug development, extensive experience with regulatory submissions, and a proven track record of leadership in a...

Job Description: Director of Program Management Join our pioneering team at Client company, a cutting-edge biotechnology company dedicated to revolutionizing healthcare through innovative drug development. At Client company, we are committed to pushing the boundaries of science to address unmet medical needs and improve patient outcomes. Our team is comprised of passionate individuals who are...

Summary / purpose of the position The Director, Medical Affairs Rare Disease (ELA) will provide support to all US medical affairs activities related to the Rare Disease- Liver portfolio, as required. The Medical Director is responsible for assisting in the delivery of asset-aligned medical strategy, including cross collaboration with key internal partners as well as managing relationships with key...

Accounting Manager PRINCIPAL DUTIES: • Obtain and maintain a thorough understanding of the financial reporting and general ledger structure.  • Manage month-end and year-end close processes, including reconciliations with the Senior Controller. • Collaborate with cross-functional teams on the month end close accrual process.  • Implement and maintain robust internal controls to...

Job Title: Medical Writer PRINCIPLE DUTIES: • Write, edit, and finalize NDA, IND, CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents  • As needed, write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents  ...

Accounts Payable Associate Key Purpose: The Accounts Payable Associate is responsible for aspects of accounts payable including vendor relations and administrative support tasks. Primary Duties + Responsibility: • Review vendor invoices against purchase orders and research any discrepancies. • Route all invoices to appropriate internal parties for approval. • Ensure accurate...

Associate Clinical Trial Manager Job Responsibilities • Drive the operational planning, content, execution, and delivery for one or more clinical trials. • Act as the main point of contact for assigned CRO and translational vendors to ensure GCP compliance and adherence to the scope of work while maintaining budgets and timelines. Responsible for trial related activities from startup to...

We are seeking a skilled scientist with expertise in antibody discovery, engineering, and characterization. This role will report to Senior Director of Antibody. This individual will play a critical role in identifying and optimizing therapeutic antibodies. The successful candidate will be primarily lab-based and will be a member of project teams; he/she may also interact with CRO partners and...

Foundry Process Engineer Role Definition: The Large Power Systems Division (LPSD) in Hodges, SC is looking for a Foundry Process Engineer to join the team. The incumbent will have the primary goal of supporting the Quality Management System within the assigned operational area, by providing expertise and advice on production or product problems fed back from both internal and external customers....

Associate Director, Quality Assurance The Associate Director, Quality Assurance is accountable and responsible for the execution and oversight of the GxP Quality Management System and Compliance activities related to the cGMP manufacture and release of products in accordance with ICH, guidelines and, US, EU, and other applicable regional regulations. This role requires leadership in a highly...

Sr. Manager- Pharmacovigilance Operations JOB SUMMARY: The Sr. Manager, Pharmacovigilance Operations provides functional area and operational support of assigned developmental and/or marketed product(s). This position will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks, contributes...

CMC Strategy Consultant Position Overview: Our client is seeking an experienced Part-Time CMC (Chemistry, Manufacturing, and Controls) Strategy Consultant to lead the strategic planning and execution of CMC activities for our Phase 3 clinical trials and potential commercial operations in the US and EU. The ideal candidate will possess deep expertise in CMC strategy and a track record of successfu...

Computational Biologist Seeking a highly motivated and experienced Senior Computational Biologist with expertise in biology and computational biology. The successful candidate will be responsible for analyzing early-stage biomarker and multi-omics data, mining publicly available data sources, and designing experiments to validate model predictions. This role requires communicating computational...

IT Service delivery manager Key Responsibilities: • Service Delivery Management: • Oversee the end-to-end delivery of IT services to ensure they meet established standards and Service Level Agreements (SLAs). • Effectively managed relationships with managed service provider partners to ensure seamless service delivery and high-quality performance. • Monitor and manage the performance...

Head of Quality Assurance and Compliance Position Summary: The Head of Quality Assurance and Compliance (QAC) is primarily responsible for the management and oversight of all aspects of QAC. Responsibilities include partnering with internal and external cross-functional stakeholders on quality related activities. This position provides quality, regulatory and technical expertise to manage...