Clinical Development Jobs in Waltham (MA)
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Search Results - Clinical Development Jobs in Waltham (MA)
Gardner Resources Consulting, LLC-Waltham (MA)
and cross-functional team representatives to orchestrate development and execution of project strategic and operational plans to meet key program goals.
Key Responsibilities:
• Facilitates development and execution of project plans including:
• Responsible...
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Initial Therapeutics, Inc.-Waltham (MA)
quantitative analytics, for the advancement of select programs across all stages of drug development at Dyne Therapeutics. Primary responsibilities include the strategic planning and execution of translational & clinical pharmacology activities, as a core...
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Confidential-Waltham (MA)
be responsible for data review and analysis, ensuring quality and identifying key trends, as well as contributing to regulatory documents and publications.The ideal candidate for this role will have experience in clinical development with a focus on oncology...
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Leading Age-Waltham (MA)
to):
• Strategic advisement on clinical development plans, design of clinical protocols.
• Responsible for safety content of IB and ICFs and support of DSMBs or Study specific safety review forums for clinical programs.
• Strategic safety input for Regulatory...
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Upstream Bio-Waltham (MA)
Position Summary:
We are seeking an experienced and proactive individual to join our team as an Associate Director/Director of Business Development at our clinical-stage biotechnology company. Reporting directly to the Head of the Business...
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Deciphera Pharmaceuticals, Inc.-Waltham (MA)
including chronic GVHD.
• Refine the market entry indication strategy plan and provide inputs on the corresponding clinical development plan and lifecycle management opportunities for DCC-3084 (Pan-RAF).
• Fully develop the commercial landscape...
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Katalyst Healthcares & Life Sciences-Waltham (MA)
and issues promptly and effectively.
Collaborate with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are integrated into product development and lifecycle processes.
Conduct...
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Clinical Dynamix, Inc.-Waltham (MA)
Responsibilities
• Accountable for project related efforts for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP...
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Lifelancer-Waltham (MA)
with drug development efforts and priorities.
Prepare all Non-Clinical safety-relevant documents to support regulatory filings including initial INDs, IND annual updates, IBs, DSURs.
Initial BLAs/review queries, as well as briefing books for US FDA, EMA...
resume-library.com -
Clinical Dynamix, Inc.-Waltham (MA)
for the delivery of studies or programs that are critical to a products clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines.
• Supports external vendor selection...
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Tbwa Chiat/Day Inc-Waltham (MA)
areas (GMP, GLP, GCP, document control, GxP training) from discovery through clinical development to launch readiness.
• Prepare quality metrics and performance indicators to measure and monitor performance of manufacturing process.
• Provide leadership...
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Apellis Pharmaceuticals, Inc.-Waltham (MA)
Duties: Draw conclusions or make predictions, based on data summaries or statistical analyses. Acts as statistical lead for multiple clinical studies and/or a clinical development program. Provide leadership and guidance on designing studies...
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