Summary of position:
Write and/or review clinical study-related documents (e.g., clinical protocols and summary reports, clinical study reports, investigator brochures and IB updates, informed consent form, clinical study data listing/table and regulatory agency/IRB submission documents), and managing internal review of study related documentsCollaborating with internal and external team members, investigators and KOLs
Participate in safety review team meetings and summarize safety findings
Clinical Scientist I/II and Sr. Clinical Scientist: CNS
Participate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing international trials
Duties and Responsibilities
* Author drafts of study synopses, protocols, protocol amendments, Monitoring Plan and informed consents for Phase II-IV studies.
* Contribute to the preparation of ...
6 month, renewable contract
w2 candidates only
The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned.
Program/project level responsibilities:
Support the development of operational plans for ...
The Clinical Scientist is responsible for the scientific strategy of assigned clinical trials for protocol development, ensuring the review/reporting of quality trial data, and study reporting/publishing in compliance with client’s processes, GCP/ICH and regulatory requirements. Supports program level activities as assigned.
Program/project level responsibilities:
• Support the development of operational plans for clinical deliverables, effectively applying principles of design ...
Shall design and develop formulations of new transdermal products.
*** Transdermal patch physical property testing and rheology testing
*** Transdermal characterization: x-ray powder diffractometry (XRPD), differential scanning calorimetry (DSC), thermogravimetric analysis (TGA), and isothermal microcalorimetry (ITMC)
*** Knowledgeable of scale-up, tech transfer, and process optimization.
*** Familiar with transdermal manufacturing unit operations and equipment such as ...
Seeking a strategic expert in the respiratory disorder field with a successful track record planning and managing all preclinical activities of novel protein therapeutics and establishing pharmaceutical and academic collaborations.
Shall manage a team of up to 10 scientists in target discovery, biomarker development, antibody generation, mechanism-of-action studies, and in vitro & in vivo models.
Requires PhD and 10+ years of respiratory biology experience.
Enjoy the career path opportunities ...
The Senior Scientist conducts advanced PK/PD modeling research utilizing available modeling techniques, with a focus on Oncology compounds. Primarily supports early development and regulatory filing activities by defining the dose-concentration-pharmacological effects relationships of drugs using modeling and simulation methodologies, from data acquired at various development stages. Performs population PK and PK/PD analysis for regulatory submission of various compounds. Uses state-of-the-art ...
Apr 29 -
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