Job Title: Senior Medical Director
Reports to: Chief Medical Officer
We are looking for a Senior Medical Director to join a highly attractive ImmunoOncology biotech start-up in San Diego. Specifically, they focus on harnessing the power of Natural Killer Cells. Although currently private, the company recently filed for IPO after receiving nearly $200 million in funding since last summer and just entered a worldwide collaboration with one of the industry's most prestigious Big Pharma companies!
Role & Responsibilities
- Work with CMO to develop clinical plans and deliver & milestones
- Write/ review clinical documents required for clinical studies (ex. clinical protocols, amendments, informed consent documents, investigator brochures, and safety management plans)
- Write/ review clinical sections of regulatory documents (ex. INDs, annual safety reports, briefing packages) and lead clinical engagement (IRBs/ Ethics committees)
- Comfortable in cross-functional disciplines (preclinical, manufacturing, quality, regulatory biostats, data management, pharmacovigilance, clinical operations, etc)
- Identify and build collaborative relationships with key opinion leaders
- Create/ prepare various presentations
- Lead ongoing data review, analysis, and interpretation to understand safety and efficacy profile of ours and our competitors' clinical programs.
- Present clinical program at Site Initiation Visits, Investigator's Meetings, and scientific conferences.
- Serve as medical point of contact with sites: answer site questions about patient eligibility, enrollment and provide clinical input into patient safety assessment and management.
- Review and assist in the creation of data analysis plans, case report forms, study reference manuals, laboratory and biomarker manuals, patient diaries, and drug accountability forms.
- MD Educated (Boarded in Oncology or Hematology is a plus)
- 5+ industry experience
- Familiar with Clinical Development (early phase is a plus)
- Experience with the FDA for IND, NDA and BLA submissions
- Remote (Relocation if needed)
- highly experienced professionals from clinical to regulatory to CMC to research
- work with cutting edge of cell therapy in an entrepreneurial, highly collaborative and innovative space
- Competitive compensation + bonus
- Equity program
- Base starts at 290k +bonus/ stock + equity
- Health and welfare benefits (Medical, Dental, Vision, Life, 401K, EAP)