A Senior Early Clinical Lead has the following roles.
Qualifications: Desired Background and Experience
- Serves as a medical and scientific expert to drug discovery teams and contributes to selection of discovery compounds, development of clinical strategy and transition of compounds into early phase development.
- Leads the design and develops clinical studies and research plans in support of asset strategy. Clinical studies range from first-in-human Phase I, proof of concept Phase I/II, entry registrational studies, and clinical pharmacology protocols.
- Identifies and provides recommendations to mitigate program and study risks/issues
- Leads strategy development and provides advice for the translational medicine strategy for an asset as part of a multi-functional team
- Leads the execution of clinical studies and interpretation of data and makes appropriate recommendations based on these data.
- Contributes to the writing, review and publishing of reports submitted to regulatory agencies
- Builds relationships with thought leaders and principal investigators and gathers input on disease areas and design of clinical programs.
- Contributes to continuous improvement initiatives, effective team-building and effective communication across the BMS Oncology community
- Qualified individuals must possess an MD, MD/PhD, PhD, or Pharm D
- Nine (9) years of related experience
- Prior experience planning, developing, and executing early clinical development studies including selection of relevant biomarkers and pharmacodynamic endpoints.
- Prior experience using scientific methods to test hypotheses, statistically design, analyze, interpret, and report results
- Proven ability to function independently in the design and conduct of clinical trials and in the assessment of issues/risks and generate potential and effective solutions.
- Prior experience addressing Health Authority and IRB questions
- Applicants should have strong leadership skills, yet be able to work effectively in a team environment
- Excellent communication skills, the ability to deliver effective presentations and strong networking abilities and creativity
- Experience as a matrix leader or leading in a matrix environment including study teams