Key skills
Communication
About this role
Role Overview
- Lead the development and execution of the Clinical Development (CD) strategy and plan for assigned molecule(s)/indication(s)
- Support the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s)
- Collaborate with various internal/external partners & stakeholders, including multidisciplinary internal groups
- Participate in meetings, reviews, discussions and interactions regarding early development/Phase I studies
- Take an active role with regulatory partners/stakeholders in the completion and submission of regulatory filings and documentation
- Ensure strategic and operational alignment of the CDP with the relevant CD strategy, strategic and annual LCP
- Work as a Medical Monitor for ongoing clinical trials.
Requirements
- Board Certified/Board Eligible (or its equivalent) MD (MBBS), MD(MBBS)/PhD physician in endocrinology, cardiology, gastroenterology, hepatology, obesity medicine and/or substantial cardiovascular, metabolic, diabetes specific research and clinical experience
- 5+ years of post-grad relevant clinical/scientific research and/or clinical trial experience
- Demonstrated experience working as a medical monitor for clinical trials
- Demonstrated the ability to foster and promote a highly productive and inclusive team-based culture in fast-paced clinical and/or research settings
- Significant experience working with the principles and techniques of data analysis, interpretation and clinical relevance, and demonstrated experience in scientific writing (e.g. manuscripts, grants, scientific protocols, health authority documents)
- Outstanding communication skills in both long-form scientific presentation and short-form communication of complex scientific topics
- Ability to collaborate with relevant team members to measure and monitor study progress against objectives and plans, including any variances, and proactively communicate any issues, challenges and potential strategies to resolve
- Demonstrated experience working with various clinical trial designs
- Sound knowledge of the pharma/biotech industry, the multiple functions and roles involved in the drug development process.
Benefits
- Relocation benefits available