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Required Skills & Experience: Bachelor's degree or higher in a scientific or healthcare discipline (advanced degree a plus), with 10+ years of progressive experience in data management within biotech, pharmaceutical, or CRO settings, including prior line-management / people leadership experience. In depth knowledge of clinical data management systems (eg: Medidata Rave Veeva Vault CDMS) required; working familiarity with data review, visualization, and analytics tools (e.g., SAS, R/Python, Spotfire, Power BI, J-Review, or elluminate).

YEAR

Stoke Therapeutics Inc

Director, Clinical Data Management

Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington's disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. By submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties.

WAVE Life Sciences

Director, Quality Systems

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Partner with Search lead as key liaison between internal cross-functional teams and external partners, organizing meetings with external companies and orchestrating scientific, clinical, regulatory, and commercial assessments to support informed decision-making. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Plasma

Director, Project Management Due Diligence

Provide leadership on GCP and GLP QA support and guidance to key clinical and non-clinical stakeholders, leveraging analysis and interpretation of GCP/GLP regulations to ensure best practices in Clinical, Non-clinical and QA operations. This role partners closely with Clinical Development, Clinical Operations, Pharmacovigilance, Non-Clinical Development & Toxicology, and Research, ensuring end-to-end regulatory compliance, scientific integrity, and patient safety.

Sarepta Therapeutics Inc

Director, Corporate Quality - GCP

Zenas' earlier stage programs include ZB021, a clinical-stage, potentially best-in-class, oral, IL-17AA/AF inhibitor; ZB022, a preclinical, potentially best-in-class, oral, brain-penetrant, TYK2 inhibitor; and ZB014, a preclinical half-life extended anti-CD-19 and FcRIIb monoclonal antibody. Serve as a subject matter expert on key technical aspects of cell-based assay development, including protein conjugation, antibody screening, assay diluent formulation, preanalytical sample processing, scale-up, assay optimization, troubleshooting, data analysis, and analytical method validation.

Zenas BioPharma (USA) LLC

Director, Analytical Development and Quality Control Biologics

We use our novel SkySTAR platform (Skyhawk Small molecule Therapeutics for Alternative splicing of RNA) to develop drug candidates directed toward targets for some of the world's most intractable diseases including neurological conditions, cancer, and traditionally "undruggable" targets. Lead and partner with cross-functional teams (Biostatistics, Clinical Operations, Regulatory, Data Management) to direct internal exploratory analyses and inform strategic decisions.

Skyhawk Therapeutics Inc

Director / Senior Director of Statistical Programming

The Associate Director, Quality Operations will act as the primary quality liaison for CMOs, CDMOs, testing laboratories, distributors, and logistics partners and support batch certification by Viridian's contracted Qualified Person (QP). Reporting to the Director, Quality Operations, the Associate Director, Quality Operations will lead quality oversight of Viridian's external manufacturing and supply network supporting EU and international operations.

Director Of Education Jobs in Grand Blanc, MI

Director, Clinical Data Management Stoke Therapeutics Inc

Director, Quality Systems WAVE Life Sciences

Director, Project Management Due Diligence CSL Plasma

Director, Corporate Quality - GCP Sarepta Therapeutics Inc

Director, Analytical Development and Quality Control Biologics Zenas BioPharma (USA) LLC

Director / Senior Director of Statistical Programming Skyhawk Therapeutics Inc

Associate Director, Quality Operations Viridian Therapeutics Inc

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