Clinical Development Jobs in Waltham (MA)
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Search Results - Clinical Development Jobs in Waltham (MA)
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...
mindmatch.ai -
AbbVie-Waltham (MA)
Leads and other clinical development team members to facilitate science-based CDx decision making and support the execution of CDx development strategy for AbbVie programs across therapeutic areas. The successful candidate will have experience...
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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...
appcast.io -
Lifelancer-Waltham (MA)
α4β7, TL1A, and IL-23.
Role Summary
Spyre Therapeutics is seeking an exceptional candidate to join our Quality team. The Director GCP Quality is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development...
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Dyne Tx-Waltham (MA)
pharmacometrics & 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...
appcast.io -
AbbVie-Waltham (MA)
is aligned closely with the clinical/regulatory development strategy and provide drug development experience and advice as appropriate to the CMC team.
Responsibilities
List up to 10 main responsibilities for the job. Include information about...
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Upstream Bio-Waltham (MA)
professional with deep expertise in biostatistics, clinical trials, and regulatory requirements. The Director will ensure the integrity, quality, and compliance of statistical analyses, contributing to the successful development and approval of new therapies...
mindmatch.ai -
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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Sionna Therapeutics-Waltham (MA)
and vendor partners
• Responsible for the development and management of clinical study documents including, but not limited to, Protocols and amendments, Informed Consent Forms (ICFs), Protocol Administrative Clarifications/Notes to File, confidentiality...
mindmatch.ai -
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...
jobvertise.com -
Lifelancer-Waltham (MA)
programmer at a program level
Provide statistical input to strategic planning, study design, protocol development, sample size calculation, CRF, Results Interpretation, clinical study report, and address questions from regulatory agencies.
Author...
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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...
jobvertise.com -
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 -
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