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Be part of making the entire Research & Development cycle digitally-enabled: improving clinical trials and data collection, Digital therapeutics for rapid diagnostic, wearables, machine learning and visual analytics for informed decision-making, integrated data to improve patient outcomes, and insights to inform the next generation of products.
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The role represents the CPQP function on drug development teams, leads CPQP sub-teams, and owns strategy and delivery on posology for early and late-stage clinical trials while collaborating with clinicians, clinical operations, bioanalytical, biomarker, pharmacovigilance, regulatory and CMC groups.
Full-timeExpandApply NowActive JobUpdated 21 days ago - UpvoteDownvoteShare Job
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Final batch disposition of all GMP materials for release into clinical trials encompassing batch record review, change control and investigations. The Associate Director, GMP Quality Operations will be the primary quality contact for quality oversight of GMP operations performed at Stoke’s CMOs and CTLs regarding process tech-transfer, scale-up, process validation and manufacture and of Stoke IMPs. This person will lead initiatives for the Quality relationship and partnership collaboration with CMOs to deliver product compliant with cGMPs, regulations (e.g., FDA, EMA, etc.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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We are using models early to fail less often, executing clinical trials to add valuation to the company, and generating fit-for-purpose data to feed back into Valo’s Opal Computational Platform™ as we reinvent drug discovery and development from the ground up.
Full-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.
$318,800 a yearFull-timeExpandApply NowActive JobUpdated 5 days ago - UpvoteDownvoteShare Job
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Since its founding in 2000, the firm has originated and fostered over 100 scientific ventures, generating more than $34 billion in aggregate value and conducting over 50 clinical trials for novel therapeutic agents.
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Thorough understanding of the drug development process from IND through NDA, including novel clinical study designs, application of companion diagnostics for patient selection, clinical operations, and pharmacovigilance.
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Solid understanding of industry standards applicable to clinical study data and reporting on clinical trials, including CDISC standards. Participate in continuous improvement activity and process reengineering in support of Biontech’s continuous improvement and global clinical initiatives.
Full-timeExpandApply NowActive JobUpdated 6+ months ago - UpvoteDownvoteShare Job
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In depth knowledge of drug development process and oversight of clinical trials. The individual must have strong team leadership skills and have deep knowledge of the clinical drug development process, spanning early/translational phases through to registration.
$225,000 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.
$233,500 a yearFull-timeExpandApply NowActive JobUpdated 29 days ago - UpvoteDownvoteShare Job
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The position will work with investigators, the General Counsel’s Office, the Clinical Trials Office, the Technology Ventures Office, Institutional Review Board, and other institutional offices to oversee the negotiation of Subcontracts, Clinical Trial Agreements, Data Use Agreements, Billing Agreements, and other atypical agreements.
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Advanced knowledge of the pharmaceutical drug development process and current knowledge of FDA regulations for clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is a plus.
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Ou will have experience in the drug development process, particularly early phase clinical trials, protocol writing and study conduct, data review and reconciliation, and what it takes to lead teams successfully.
Full-timeExpandApply NowActive JobUpdated 16 days ago - UpvoteDownvoteShare Job
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The Director, Site Contracts, Budgets & Payments plays key role in operational leadership role in delivering finalized clinical trial agreements and budgets in a timely fashion to ensure clinical trials are started and executed within corporate and Program team timelines.
Full-timeExpandApply NowActive JobUpdated 9 days ago - UpvoteDownvoteShare Job
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7+ years of clinical trial experience in a pharmaceutical, biotech, hospital setting, or CRO is required with at least 5 years managing clinical trials. We are partnering with a Massachusetts-based Biotech to help them add a Manager of GCP Quality Assurance who will provide expertise and guidance on Good Clinical Practice (GCP), and applicable regulations to clinical and nonclinical development teams to proactively identify compliance issues/risks and recommend mitigation.
$175,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago
process clinical trials jobs Title: director in Boston, MA
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