Responsibilities will include, but are not limited to, the following:
•Plan and execute the following:
oClinical Pharmacology studies for medicines development from first-in-human through post-marketing phases;
oInnovative small studies in patients to support advancement of drug candidates to Phase 2;oBiomarker qualification studies.
•Work with statisticians, laboratory colleagues to optimally interpret and report results of completed studies.
•Design early development plans for drug candidates.
•Contribute to regulatory filings, dossiers, and updates. Collaborate with counterparts in regulatory agencies.
•Work with external and internal scientists to identify and validate new drug targets and related biomarkers.
•Work on cross-disciplinary teams to evaluate opportunities for licensing or acquisition.
•Engage in continuous learning around basic and clinical science.
•Facilitate ongoing improvement of research approaches.
•Represent Clinical Pharmacology on project teams and in governance proceedings.
•Mentor and direct others as needed.
•Travel as needed to other Celgene sites, and collaborating sites, regulatory meetings, and professional/scientific meetings. (5%-10%)
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.