Assoc Med Director / Med Director / Sr Med Director
Responsible for the design, execution, analysis, interpretation and presentation of clinical and translational studies, primarily for inflammation or oncology indications. Participates in the development and execution of strategies for new product development and lifecycle growth, including regulatory and investigator interactions as applicable.
• Provides medical strategic leadership for clinical and translational projects
• Plans, organizes, and directs the activities of oncology and/or inflammation and related clinical trials, including development of clinical protocols and amendments, investigator brochures, and clinical study reports
• Provides medical monitoring support, including evaluation of safety, pharmacology and efficacy of ongoing and completed studies
• Establishes and implements exploratory pharmacodynamic, diagnostic, and biomarker plans in conjunction with partners in clinical pharmacology and diagnostics/biomarkers
• Interacts with external thought leaders, including advisory boards, to support clinical and translational development
• Prepares literature reviews and publications as appropriate
• MD or MD/PhD or equivalent in oncology, hematology, rheumatology or related field. Board certification is preferred.
• Clinical drug development experience in oncology and inflammation. Early development (first-in-human thru proof-of-concept) required, late development including NDA/BLA/MA experience desrired.
• Experience with and strong understanding of translational disease biology and translational medicine in oncology and immunology. Experience and/or interest in biologic therapeutics would be preferred.
• Excellent specialty professional reputation and working relationships
• Working experience in the pharmaceutical industry preferred.
• Ability to communicate efficiently with preclinical, biomarker, biostatistical and computational scientists, as well as clinical and commercial colleagues, who may be outsourced and/or remote. Ability to explain medical and scientific technical issues to technical and non-technical staff