- Provide subject matter expertise to inform the clinical development plan for each asset tested in autoimmune neurological disorders
- Organize and lead clinical development advisory boards and safety monitoring boards
- Author clinical documents to support regulatory submissions from IND through BLA/MA
- Represent Clinical Development in the selection and monitoring of CRO and external laboratory activities
- Work with Data Management in the design of electronic case report forms
- Work with Translational Medicine and Clinical Operations to design a feasible and cost-effective sample acquisition and biomarker testing schedule
- Collaborate with Clinical Operations to engage, recruit, and activate academic and non-academic sites for clinical trial participation
- Serve as the point-of-contact for clinical sites on matters of protocol-specified eligibility, treatment, monitoring, and assessments
- Aid Clinical Logistics, Technical Operations, and Quality in the scheduling of patient leukapheresis and product release
- Organize and lead routine investigator calls
- Review and analyze clinical data from company-sponsored clinical studies
- Ensure that the reported data is accurate, complete, and verifiable
- Review listings for coded terms consistent with the Medical Dictionary for Regulatory Activities (MedDRA) and WHODrug
- Ensure that the trial is conducted in compliance with the currently approved protocol
- Address safety issues across studies and assist in Pharmacovigilance activities
- Collaborate with Project Management, Clinical Operations, and all departments in the preparation of annual IND reports, clinical study reports, manuscripts, and scientific presentations
- Identify study and program risks, and create and implement mitigation strategies with Clinical Operations
- Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
- Review and sign off on clinical documents with respect to medical relevance
- Summarize, interpret, and distribute findings from abstracts and publications relevant to the clinical development of company assets
- Collaborate with Medical Affairs to deliver accurate, succinct, and timely communication of clinical and scientific presentations to healthcare professionals, proactively and in response to requests for information, in accordance with regulatory requirements and promotional compliance
- Assist Corporate Development in diligence activities and competitive intelligence
- American Board of Psychiatry or Neurology eligible or certified
- Minimum 10 years clinical research experience with at least 5 years in the Biotechnology or Pharmaceutical industry
- 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
- Experienced with FDA interactions leading to drug approval strongly preferred
- West Hills, California, or Hybrid
- Up to 20% travel
- Willingness to travel domestically and internationally for business meetings and scientific conferences. Travel as required to meet with the clinical site team, CRO, ImmPACT Bio team, and company leadership in West Hills, CA company headquarters
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Senior Medical Director, Clinical Development - Los Angeles, United States - ImmPACT Bio
Description
ImmPACT Bio USA, Inc., is a clinical-stage company dedicated to the discovery of transformative chimeric antigen receptor (CAR) T-cell therapies that address key biological challenges in treating cancer and autoimmune diseases. The company's logic-gate-based CAR T-cell platforms, licensed from University of California, Los Angeles (UCLA) Technology Development Group, are specifically designed to deplete B cells, prevent antigen escape, and overcome the immunosuppressive tumor microenvironment. The company's technology is based on the work of pioneering scientists Yvonne Chen, Ph.D., and Antoni Ribas, M.D., Ph.D., both from UCLA.ImmPACT Bio is looking for an exceptional individual to join our growing team as Senior 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 autoimmune neurological disorders.
Primary Responsibilities:
Compensation for the role will depend on several factors, including a candidate's qualifications, skills, competencies, and experience.
Salary Range
$310,000-$375,000 USD
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.
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