We are seeking a Medical Director to be 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. Title and compensation commensurate with level of experience.
- 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
Desired Skills and Experience:
- 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 desired.
- 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
- Entrepreneurial, enjoys working in a fast-paced, small-company environment. Ability to function well with volatility, uncertainty, complexity, and ambiguity; to take disparate inputs and drive them into one cohesive strategic regulatory decision; to work under pressure, meeting time sensitive deadlines, while maintaining a high level of quality.
Alpine team members enjoy competitive salaries, equity participation (stock options), and an excellent benefits package including health and life insurance, a 401(k), and generous paid time off benefits.