Actalent Medical Director in Boston, Massachusetts
Provide strategic leadership in the existing and planned clinical programs to support global filings
Medical monitor for multiple ongoing clinical trials, including evaluation of clinical and laboratory data, assessing safety, responsibility for dose escalation decisions in phase 1, and assessing early pharmacodynamics and clinical signals of activity
Coordinate activities with translational medicine colleagues to develop biomarker strategies for and interpret data generated from clinical trials
Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are correct and presented with the appropriate medical interpretation
Work closely with regulatory affairs, and consultants to assure timely filing of all clinical applications
Work closely with Pharmacovigilance on development of Risk Management Plans
Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws
2-5+ years of proven ability in the biotechnology or pharmaceutical industry including direct experience leading, OR 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
Experience in adult or pediatric oncology, hematology, rare disease, or allergy
Experience with high-complexity first-in-human studies is highly desired
An M.D., D.O., N.P., P.A. or comparable advanced practice degree
Seeking background in hematology, solid tumor oncology, or allergy
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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