Job Description: Director/Senior Director, Drug Product Development This individual will serve as an integral team member with exposure to multiple facets of business operations. The Director/Senior Director, Drug Product Development will lead drug product formulation and filling process development as well as cGMP manufacturing at Client company’s CDMOs. Additional features of the position...

JOB SUMMARY: Seeking a highly skilled and experienced Oncology Medical Director to join our dynamic team. The successful candidate will have a strong background in oncology, extensive experience in Phase III clinical studies, and a proven track record in managing global clinical trials. This role is pivotal in driving the clinical development of our oncology pipeline and ensuring the successful...

Job Title: Associate Director, Clinical Operations Salary: $165,000-$180,000 JOB SUMMARY: Looking for an experienced Clinical Operations professional. The Associate Director, Clinical Operations will report to the Vice President, Clinical Operations. The role is primarily responsible for close interactive oversight to ensure exceptional execution of Oncology clinical studies. The Associate...

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 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  Write...

Job Title: GCP Auditor Consultant Description: The Senior GCP Auditor Consultant will play a critical role in ensuring compliance with Good Clinical Practice (GCP) guidelines across all clinical trials conducted. This individual will be responsible for planning, conducting, and reporting on GCP audits to ensure the integrity and quality of clinical data and safety of trial participants. The ideal...

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 of IT...

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 safeguard company...

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...

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...

Director of Scientific Communications JOB SUMMARY: The Director of Scientific Communications will lead the development and execution of a strategic scientific communication plan, and be accountable for innovative, competitive and impactful medical communications over the life cycle of assets The Director will regularly work cross-functionally within the organization as well as with external...