Provides independent medical and scientific guidance for clinical development and medical affairs work across early- to late-stage drug and medical device programs. The role focuses on study design, protocol refinement, patient recruitment strategy, trial feasibility, compliance review, and risk assessment across multiple therapeutic areas, including oncology, cardiology, immunology, ophthalmology, gout and metabolic disorders. It also involves close collaboration with internal cross-functional teams, external investigators, and academic partners, along with scientific training and congress-based insights to support global programs.
Key Responsibilities
- Deliver independent medical and scientific advice for global medical affairs and clinical development activities across multiple therapeutic areas.
- Provide guidance on clinical study design, patient recruitment strategy, protocol refinement, and trial feasibility.
- Review study execution plans and support quality control, progress tracking, and standardized trial implementation across Phases I–IV.
- Maintain scientific communication with KOLs, principal investigators, patient advocacy groups, and medical professional societies.
- Attend congresses, forums, and academic meetings to gather clinical insights, scientific updates, and competitor intelligence.
- Review medical and scientific materials for accuracy, scientific rationale, and regulatory compliance.
- Conduct medical risk assessments for clinical trials and recommend mitigation strategies for patient safety and follow-up.
- Provide training to clinical, operations, and regulatory teams on scientific messaging and clinical judgment.
Required
- MD or equivalent recognized medical degree.
- At least 5 years of clinical development experience in the pharmaceutical, biotech, or CRO industry.
- Experience covering full-cycle clinical activities across Phase I–IV for drugs or medical devices.
- Ability to interpret, analyze, and present clinical trial efficacy and safety data.
- Strong knowledge of global clinical development, multi-region trial design, and regulatory compliance requirements.
- Excellent written and verbal communication skills with strong cross-functional collaboration ability.
Preferred
- Experience in cell therapy, immuno-oncology, hematologic malignancies, or medical device clinical trials.
- Prior service as a principal investigator or sub-investigator for multi-center clinical trials.
- Previous experience as a medical expert or committee consultant for CRO, biotech, or medical device organizations.