Massachusetts Veterans Jobs

Description

• 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

Skills:

• 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

Education:

• An M.D., D.O., N.P., P.A. or comparable advanced practice degree

• Seeking background in hematology, solid tumor oncology, or allergy

  About Actalent:

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.