该职位来源于猎聘 We are seeking a Medical Director to lead clinical trials for gene-editing based therapeutics. The role requires a resourceful, well-organized, strategic focused individual to drive multiple operational tasks. The candidate will work closely with clinical operations, researchers, and external CROs to bring early projects into clinical development.
Responsibilities
- Design robust clinical studies
- Develop clinical study protocols and associated clinical study documents
- Identify and establish relationships with KOLs and principal investigators
- Select clinical investigators; providing guidance to investigators on a study.
- Collaborate in developing global regulatory plans and play a key role in regulatory meetings in partnership with regulatory affairs.
- Provide medical supervision for contract research organizations and protocol procedures.
- Provide medical and scientific input in review of clinical data, patient medical safety data, and laboratory data.
- Provide medical surveillance on Adverse Event (AE), Serious Adverse Event (SAE) reporting, and follow-ups.
- Author, review written materials and provide editorial comments for clinical study reports and manuscripts.
- Develop budgets and timelines for the clinical development team.
Minimum Qualifications
- Master or Doctor of medicine is required.
- Formal training in the areas of Internal Medicine /Pediatrics / Endocrinology /Neurology or related fields.
- A minimum of 2+ years of clinical trials and managerial experience in drug development
- Excellent interpersonal and public speaking skills are required for this high visibility position.
- Demonstrated ability to work in a matrix environment with cross-functional teams. Preferred Qualifications:
- Experience in rare disease would be a plus.
- NDA / BLA experience is strongly preferred.
- Global clinical development experience is required, and global filing experience is strongly preferred.
- Background in gene therapy is preferred.
- Experience in pre-clinical development is preferred.
- Portfolio management experience would be a plus.