Medical Director, Clinical Development
ImmPACT Bio USA
ImmPACT Bio is a clinical-stage company, headquartered in the Los Angeles area, developing novel cell therapies for treating cancer and autoimmune disease. The company’s next-generation chimeric antigen receptor (CAR)-T cell technologies are based on Boolean logic-gate approaches and address key biological challenges for engineered T cell therapies including relapse due to antigen loss/escape; on-target, off-tumor toxicities; and the immunosuppressive tumor microenvironment.
ImmPACT Bio is looking for an exceptional individual to join our growing team as Medical Director. This position will report directly to the Chief Medical Officer and be responsible for participation in all aspects of clinical development, working collaboratively with the Clinical Study Team and contributing to the strategic planning and execution of clinical plans in hematology and oncology.
- Interact with clinical sites on matters of protocol specified eligibility, treatment, monitoring, and assessments
- Review and analyze clinical data from company sponsored clinical studies
- Ensure that the reported data is accurate, complete, and verifiable
- Review listings for coded events to verify Medical Dictionary for Regulatory Activities (MedDRA)
- Ensure that the trial is conducted in compliance with the currently approved protocol
- Address safety issues across the studies
- Assist in Pharmacovigilance activities
- Collaborate with Project Management, Clinical Operations, and all departments in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and scientific presentations
- Identify study and program risks, and create and implement mitigation strategies with Clinical Operations
- Organize and lead clinical development advisory boards and safety monitoring boards
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off on clinical documents with respect to medical relevance
- M.D. degree, PharmD, or MSN required
- Minimum 5 years oncology or hematology clinical research experience
- Familiar with early and late phase clinical trial design
- Knowledgeable of FDA guidance regarding clinical research trials
- Able to interact with and train clinical monitors and physician investigators, and build constructive, trusting, and respectful relationships with colleagues at all levels within and outside the organization
- Must possess excellent leadership, communication, and organizational skills and be able to exercise sound critical thinking and problem-solving skills and execute position responsibilities with minimal guidance
- Board Certified hematologist and/or medical oncologist preferred
- Experienced with FDA interactions leading to drug approval strongly preferred
Compensation for the role will depend on several factors, including a candidate’s qualifications, skills, competencies, and experience.
ImmPACT Bio provides a generous Total Rewards package, to include a competitive base salary, bonus, and equity package as well as generous benefits and paid time off programs. ImmPACT Bio is an Equal Opportunity Employer and will review all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. All information will be kept confidential according to EEO guidelines.